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Positional Therapy After Stroke

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ClinicalTrials.gov Identifier: NCT01047709
Recruitment Status : Completed
First Posted : January 13, 2010
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sleep Apnea
Stroke
Intervention Device: Positional therapy including the use of a special pillow
Enrollment 18
Recruitment Details This is a crossover study. One night with positional therapy (intervention) and one night of sleeping ad lib (control). The order was randomly assigned. Subjects were enrolled between 12/2008 and 2/2010.
Pre-assignment Details  
Arm/Group Title Positional Therapy Night First, Then Control Night Control Night First, Then Positional Therapy Night
Hide Arm/Group Description Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib. Position ad lib for the first night, then one night of avoidance of supine positioning.
Period Title: Positional Therapy (1 Night)
Started 9 9
Completed 9 9
Not Completed 0 0
Period Title: Control/Positioning ad Lib (1 Night)
Started 9 9
Completed 9 9
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All study participants.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  61.1%
>=65 years
7
  38.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
59  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Apnea-hypopnea Index
Hide Description Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of presumed sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe. The relative treatment effect on AHI using GEE modeling.
Time Frame 1 day
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Positional Therapy Night Control Night
Hide Arm/Group Description:
Avoidance of supine positioning.
Position ad lib
Overall Number of Participants Analyzed 18 18
Median (Inter-Quartile Range)
Unit of Measure: events/hr
27
(22 to 47)
39
(21 to 54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Positional Therapy Night, Control Night
Comments Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter relative % difference
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
4.9 to 31.9
Parameter Dispersion
Type: Standard Deviation
Value: 23
Estimation Comments SD of control night
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Positional Therapy Night, Control Night
Comments Relative treatment effect on AHI, using GEE modeling, accounting for crossover design.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method GEE
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative % difference
Estimated Value 19.5
Confidence Interval 95%
4.9 to 31.9
Parameter Dispersion
Type: Standard Deviation
Value: 16
Estimation Comments SD of intervention night
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Positional Therapy Night Control Night
Hide Arm/Group Description Avoidance of supine positioning. Position ad lib
All-Cause Mortality
Positional Therapy Night Control Night
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Positional Therapy Night Control Night
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Positional Therapy Night Control Night
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Devin Brown, MD
Organization: University of Michigan
Phone: 7349369075
Responsible Party: Devin Brown, University of Michigan
ClinicalTrials.gov Identifier: NCT01047709     History of Changes
Other Study ID Numbers: U024133
First Submitted: January 12, 2010
First Posted: January 13, 2010
Results First Submitted: January 18, 2013
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013