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Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00203996
Recruitment Status : Terminated (Did not meet target patient accrual goals)
First Posted : September 20, 2005
Results First Posted : July 16, 2013
Last Update Posted : July 22, 2013
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
David Ehrmann, University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Polycystic Ovary Syndrome
Obstructive Sleep Apnea
Interventions Device: continuous positive airway pressure (CPAP)
Drug: depot leuprolide plus estrogen/progestin replacement
Drug: pioglitazone
Procedure: REM frag
Procedure: SWS supp
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: REM Frag - SWS Supp - Baseline Aim 3: REM Frag - Baseline - SWS Supp Aim 3: Baseline - REM Frag - SWS Supp Aim 3: SWS Supp - REM Frag - Baseline Aim 3: Baseline - SWS Supp - REM Frag
Hide Arm/Group Description One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm. One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP). One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).

Each subject was assessed under three experimental conditions in the following order.

REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

Each subject was assessed under three experimental conditions in the following order.

REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

Each subject was assessed under three experimental conditions in the following order.

Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

Each subject was assessed under three experimental conditions in the following order.

SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

Each subject was assessed under three experimental conditions in the following order.

Baseline: "Baseline" sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.

SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.

REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.

Period Title: Overall Study
Started 0 0 0 19 4 3 2 4 2 3
Aim 3 Only: First Intervention 0 0 0 0 0 3 2 4 2 3
Aim 3 Only: Washout 0 0 0 0 0 3 2 2 2 2
Aim 3 Only: Second Intervention 0 0 0 0 0 3 2 2 2 2
Aim 3 Only: Second Washout 0 0 0 0 0 3 2 2 2 2
Aim 3 Only: Third Intervention 0 0 0 0 0 3 2 2 2 2
Completed 0 0 0 9 3 3 2 2 2 2
Not Completed 0 0 0 10 1 0 0 2 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             1             0             0             0             0             0             0
Protocol Violation             0             0             0             6             1             0             0             0             0             0
Physician Decision             0             0             0             2             0             0             0             0             0             1
CPAP machine malfunction             0             0             0             1             0             0             0             0             0             0
Scheduling issue             0             0             0             0             0             0             0             2             0             0
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: All Participants Total
Hide Arm/Group Description One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm. One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP). One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP). Includes groups randomized to any experimental ordering in Aim 3 Total of all reporting groups
Overall Number of Baseline Participants 0 0 0 19 4 14 37
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 0 participants 0 participants 0 participants 19 participants 4 participants 14 participants 37 participants
31.2  (5.3) 32.2  (5.8) 24.6  (2.7) 28.8  (4.4)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 19 participants 4 participants 14 participants 37 participants
Female 19 4 5 28
Male 0 0 9 9
1.Primary Outcome
Title Aim 1: Apnea–Hypopnea Index (AHI) [Baseline]
Hide Description Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to these study arms.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]
Hide Description Apnea–hypopnea index (AHI) is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to these study arms.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Primary Outcome
Title Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]
Hide Description Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.
Time Frame baseline (0 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
0.87  (0.13) 3.67  (1.01)
4.Primary Outcome
Title Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]
Hide Description Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
0.93  (0.17) 2.57  (0.34)
5.Primary Outcome
Title Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]
Hide Description Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.
Time Frame baseline (0 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
1711  (370) 695  (228)
6.Primary Outcome
Title Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]
Hide Description Acute insulin resistance to intravenous glucose (AIRg) is a measure of the secretion of insulin during the first 10 minutes after an intravenous glucose load. AIRg addresses adequacy of insulin secretion.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
1614  (385) 722  (211)
7.Primary Outcome
Title Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]
Hide Description Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.
Arm/Group Title Aim 3: REM Fragmentation Aim 3: SWS Suppression
Hide Arm/Group Description:
Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
Overall Number of Participants Analyzed 0 9
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
8.42  (1.12)
8.Primary Outcome
Title Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]
Hide Description Insulin sensitivity Index (SI) is the increase in net fractional glucose clearance rate per unit change in plasma insulin concentration after an intravenous glucose load. SI quantifies the capacity of insulin to promote glucose disposal.
Time Frame 3 nights
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to technical issues, REM fragmentation data were not analyzable. Technical issues also resulted in non-analyzable data for two subjects in the SWS suppression study, thereby decreasing the sample size from 11 to 9 subjects.
Arm/Group Title Aim 3: REM Fragmentation Aim 3: SWS Suppression
Hide Arm/Group Description:
Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
Overall Number of Participants Analyzed 0 9
Mean (Standard Error)
Unit of Measure: mU/(liter x min)
5.87  (0.74)
9.Secondary Outcome
Title Aim 1: Blood Pressure [Baseline]
Hide Description Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.
Time Frame baseline (0 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to these study arms.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Aim 1: Blood Pressure [After Treatment]
Hide Description Blood pressure is the pressure of blood within the arteries, produced primarily by the contraction of the heart muscle.
Time Frame 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to these study arms.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Aim 1: Visceral Adiposity [Baseline]
Hide Description Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.
Time Frame up to half of an hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to this arm.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Aim 1: Visceral Adiposity [After Treatment]
Hide Description Visceral adiposity refers to the degree of fat located in the peritoneal cavity (abdominal area) that surrounds the body's internal organs.
Time Frame up to half of an hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No participants were randomized to this arm.
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin
Hide Arm/Group Description:
One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]
Hide Description This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.
Time Frame 10 minutes, over a period of 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: microgram/deciliter
8.6  (0.9) 6.1  (0.2)
14.Secondary Outcome
Title Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]
Hide Description This outcome is defined as the average concentration of cortisol (a glucocorticoid produced by the adrenal gland) in the blood, measured repeatedly over a 24 hour period in each patient individually.
Time Frame 10 minutes, over a period of 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: microgram/deciliter
7.8  (0.5) 6.5  (0.2)
15.Secondary Outcome
Title Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]
Hide Description This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.
Time Frame 15 minutes over a period of 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: nanogram/milliliter
67.6  (10.5) 56.9  (1.6)
16.Secondary Outcome
Title Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]
Hide Description This outcome is defined as the average concentration of leptin (a hormone produced by the fat cells that affects feeding behavior and appetite) in the blood, measured repeatedly over a 24 hour period in each patient individually.
Time Frame 15 minutes over a period of 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The recruitment of control subjects for this protocol was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria. As a consequence, the sample size of control subjects was insufficient to allow for any meaningful conclusions to be drawn. Statistical analyses were not possible due to insufficient sample size.
Arm/Group Title Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP
Hide Arm/Group Description:
One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
Overall Number of Participants Analyzed 9 3
Mean (Standard Error)
Unit of Measure: nanogram/milliliter
65.8  (9.9) 57.4  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: REM Fragmentation Aim 3: SWS Suppression
Hide Arm/Group Description One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm. One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm. One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP). One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP). Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed. SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
All-Cause Mortality
Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: REM Fragmentation Aim 3: SWS Suppression
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: REM Fragmentation Aim 3: SWS Suppression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0      0/19 (0.00%)      0/4 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Aim 1: Placebo Aim 1: Pioglitazone Aim 1: Leuprolide + Estrogen/Progestin Aim 2: PCOS + SDB With CPAP Aim 2: Matched Controls With CPAP Aim 3: REM Fragmentation Aim 3: SWS Suppression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/0      1/19 (5.26%)      0/4 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Reproductive system and breast disorders               
Vaginal bleeding  [1]  0/0  0 0/0  0 0/0  0 1/19 (5.26%)  1 0/4 (0.00%)  0 0/14 (0.00%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Abnormal vaginal bleeding is any vaginal bleeding unrelated to normal menstruation.
No participants were randomized to any of the 3 study arms in Aim 1. Also, the recruitment of control subjects for Aim 2 was hindered by the difficulty in finding subjects who met both inclusion and exclusion criteria.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: David A. Ehrmann, MD
Organization: The University of Chicago
Phone: (773) 702-6138
Responsible Party: David Ehrmann, University of Chicago
ClinicalTrials.gov Identifier: NCT00203996     History of Changes
Other Study ID Numbers: 12861B
R01HL075079 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 20, 2005
Results First Submitted: March 5, 2013
Results First Posted: July 16, 2013
Last Update Posted: July 22, 2013