Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Stroke Clinical Trial

— BOSAST  

Official title:

Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00952211
• Other study ID #: HL091848
• Status: Terminated
• Phase: Phase 4
• First received: August 3, 2009
• Last updated: December 16, 2015
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

There are two purposes of this study. The first purpose is to define the frequency of obstructive sleep apnea in stroke survivors as well as its association with fatigue and quality of life. The second purpose is to determine if continuous positive airways pressure (CPAP) treatment can have a beneficial effect on these patients' fatigue and quality of life.

Description:

Stroke survivors frequently complain of fatigue, depressive symptoms, and decreased cognitive functioning. These burdens complicate the recovery and rehabilitation from stroke. While there may be many contributing factors to these burdens, one factor in particular may be both terribly common and yet readily susceptible to intervention. Consistent reports from around the world demonstrate that >50% of stroke patients have obstructive sleep apnea (OSA), a disorder that is also associated with fatigue, depressive symptoms, and decreased cognitive functioning. OSA is also associated with increases in inflammatory products which themselves are associated with the same array of burdens.

This study will examine inpatients at a stroke rehabilitation center. Patients' sleep will be studied. Patients with OSA will be randomized to 10 days treatment double blind with either continuous positive airways pressure (CPAP) treatment or to sub-therapeutic CPAP treatment. After 10 days of treatment, the OSA patients and the stroke patient without OSA will be restudied.

The study will shed light on the impact of OSA on stroke patients' burdens.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• stroke survivor in stroke rehabilitation unit

• age 45-85

• able to consent

• no prior treatment with CPAP

Exclusion Criteria:

• complex apnea

• known inflammatory disease

• neurological disease precluding patient's ability to consent and cooperate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stroke

Intervention

Device:
• CPAP
CPAP at therapeutic pressure during nighttime
• CPAP at sub-therapeutic pressure
CPAP delivered at sub-therapeutic pressure at nighttime

Locations

Country	Name	City	State
United States	UCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue		10 days after beginning CPAP treatment	No
Secondary	quality of life		10 days after beginning CPAP treatment	No