Trial Outcomes & Findings for Positional Therapy After Stroke (NCT NCT01047709)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

1 day

Results posted on

2013-06-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Positional Therapy Night First, Then Control Night Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.	Control Night First, Then Positional Therapy Night Position ad lib for the first night, then one night of avoidance of supine positioning.
Positional Therapy (1 Night) STARTED	9	9
Positional Therapy (1 Night) COMPLETED	9	9
Positional Therapy (1 Night) NOT COMPLETED	0	0
Control/Positioning ad Lib (1 Night) STARTED	9	9
Control/Positioning ad Lib (1 Night) COMPLETED	9	9
Control/Positioning ad Lib (1 Night) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Positional Therapy After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=18 Participants All study participants.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

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.

Outcome measures

Outcome measures
Measure	Positional Therapy Night n=18 Participants Avoidance of supine positioning.	Control Night n=18 Participants Position ad lib
Apnea-hypopnea Index	27 events/hr Interval 22.0 to 47.0	39 events/hr Interval 21.0 to 54.0

Adverse Events

Positional Therapy Night

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Night

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Devin Brown, MD

University of Michigan

Phone: 7349369075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place