Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

NCT ID: NCT00952211

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-06-30

Brief 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.

Detailed 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.

Conditions

Stroke; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

CPAP

CPAP at therapeutic pressure

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

CPAP at therapeutic pressure during nighttime

sub-therapeutic CPAP

CPAP administered at sub-therapeutic pressure

Group Type: SHAM_COMPARATOR

CPAP at sub-therapeutic pressure

Intervention Type: DEVICE

CPAP delivered at sub-therapeutic pressure at nighttime

Interventions

CPAP

CPAP at therapeutic pressure during nighttime

Intervention Type: DEVICE

CPAP at sub-therapeutic pressure

CPAP delivered at sub-therapeutic pressure at nighttime

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Joel E. Dimsdale, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Dimsdale, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

UCSD

San Diego, California, United States

Countries

United States

References

Tomfohr LM, Hemmen T, Natarajan L, Ancoli-Israel S, Loredo JS, Heaton RK, Bardwell W, Mills PJ, Lee RR, Dimsdale JE. Continuous positive airway pressure for treatment of obstructive sleep apnea in stroke survivors: what do we really know? Stroke. 2012 Nov;43(11):3118-23. doi: 10.1161/STROKEAHA.112.666248. Epub 2012 Sep 27. No abstract available.

Reference Type: DERIVED

PMID: 23019248 (View on PubMed)

Other Identifiers

HL091848

Identifier Type: -

Identifier Source: org_study_id