Polycystic Ovary Syndrome (PCOS) and Sleep Apnea

This study has been terminated.
(Did not meet target patient accrual goals)
Sponsor:
Collaborators:
Information provided by (Responsible Party):
David Ehrmann, University of Chicago
ClinicalTrials.gov Identifier:
NCT00203996
First received: September 13, 2005
Last updated: July 16, 2013
Last verified: July 2013
Results First Received: March 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Aim 1: Placebo One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
Aim 1: Pioglitazone One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
Aim 1: Leuprolide + Estrogen/Progestin One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Aim 2: PCOS + SDB With CPAP 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).
Aim 2: Matched Controls With 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).
Aim 3: REM Frag - SWS Supp - Baseline

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.

Aim 3: REM Frag - Baseline - SWS Supp

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.

Aim 3: Baseline - REM Frag - SWS Supp

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.

Aim 3: SWS Supp - REM Frag - Baseline

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.

Aim 3: Baseline - SWS Supp - REM Frag

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.


Participant Flow:   Overall Study
    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  
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  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Aim 1: Placebo One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
Aim 1: Pioglitazone One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
Aim 1: Leuprolide + Estrogen/Progestin One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
Aim 2: PCOS + SDB With CPAP 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).
Aim 2: Matched Controls With 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).
Aim 3: All Participants Includes groups randomized to any experimental ordering in Aim 3
Total Total of all reporting groups

Baseline Measures
    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  
Number of Participants  
[units: participants]
  0     0     0     19     4     14     37  
Age  
[units: years]
Mean ± Standard Deviation
              31.2  ± 5.3     32.2  ± 5.8     24.6  ± 2.7     28.8  ± 4.4  
Gender  
[units: participants]
             
Female                 19     4     5     28  
Male                 0     0     9     9  



  Outcome Measures
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1.  Primary:   Aim 1: Apnea–Hypopnea Index (AHI) [Baseline]   [ Time Frame: baseline ]

2.  Primary:   Aim 1: Apnea-hypopnea Index (AHI) [After Treatment]   [ Time Frame: 8 weeks ]

3.  Primary:   Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]   [ Time Frame: baseline (0 weeks) ]

4.  Primary:   Aim 2: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After CPAP]   [ Time Frame: 8 weeks ]

5.  Primary:   Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [Baseline]   [ Time Frame: baseline (0 weeks) ]

6.  Primary:   Aim 2: Acute Insulin Resistance to Intravenous Glucose (AIRg) [After CPAP]   [ Time Frame: 8 weeks ]

7.  Primary:   Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [Baseline]   [ Time Frame: Baseline ]

8.  Primary:   Aim 3: Insulin Sensitivity Index (SI) From Intravenous Glucose Tolerance Test [After 3 Nights of SWS Suppression]   [ Time Frame: 3 nights ]

9.  Secondary:   Aim 1: Blood Pressure [Baseline]   [ Time Frame: baseline (0 weeks) ]

10.  Secondary:   Aim 1: Blood Pressure [After Treatment]   [ Time Frame: 8 weeks ]

11.  Secondary:   Aim 1: Visceral Adiposity [Baseline]   [ Time Frame: up to half of an hour ]

12.  Secondary:   Aim 1: Visceral Adiposity [After Treatment]   [ Time Frame: up to half of an hour ]

13.  Secondary:   Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [Baseline]   [ Time Frame: 10 minutes, over a period of 24 hours ]

14.  Secondary:   Aim 2: Mean Cortisol Levels Over 24 Hours, Per Patient [After Treatment]   [ Time Frame: 10 minutes, over a period of 24 hours ]

15.  Secondary:   Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [Baseline]   [ Time Frame: 15 minutes over a period of 24 hours ]

16.  Secondary:   Aim 2: Mean Leptin Levels Over 24 Hours, Per Patient [After Treatment]   [ Time Frame: 15 minutes over a period of 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: dehrmann@medicine.bsd.uchicago.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: David Ehrmann, University of Chicago
ClinicalTrials.gov Identifier: NCT00203996     History of Changes
Other Study ID Numbers: 12861B, R01HL075079
Study First Received: September 13, 2005
Results First Received: March 5, 2013
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board