Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

University of California San Diego

Status and phase: Terminated; Phase 4

Conditions: Stroke; Obstructive Sleep Apnea

Treatments: Device: CPAP; Device: CPAP at sub-therapeutic pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT00952211

HL091848

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

CPAP

Active Comparator group

Description:

CPAP at therapeutic pressure

Treatment:

Device: CPAP

sub-therapeutic CPAP

Sham Comparator group

Description:

CPAP administered at sub-therapeutic pressure

Treatment:

Device: CPAP at sub-therapeutic pressure