Positional Therapy After Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Devin Brown, University of Michigan
ClinicalTrials.gov Identifier:
NCT01047709
First received: January 12, 2010
Last updated: June 6, 2013
Last verified: June 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Sleep Apnea
Stroke
Intervention: Device: Positional therapy including the use of a special pillow

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

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Positional Therapy (1 Night)
    Positional Therapy Night First, Then Control Night     Control Night First, Then Positional Therapy Night  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     0     0  

Period 2:   Control/Positioning ad Lib (1 Night)
    Positional Therapy Night First, Then Control Night     Control Night First, Then Positional Therapy Night  
STARTED     9     9  
COMPLETED     9     9  
NOT COMPLETED     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
All Study Participants All study participants.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     7  
Age  
[units: years]
Mean ± Standard Deviation
  59  ± 12  
Gender  
[units: participants]
 
Female     7  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures

1.  Primary:   Apnea-hypopnea Index   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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 text entered.  


Results Point of Contact:  
Name/Title: Devin Brown, MD
Organization: University of Michigan
phone: 7349369075
e-mail: devinb@umich.edu


Publications of Results:

Responsible Party: Devin Brown, University of Michigan
ClinicalTrials.gov Identifier: NCT01047709     History of Changes
Other Study ID Numbers: U024133
Study First Received: January 12, 2010
Results First Received: January 18, 2013
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board