Trial Outcomes & Findings for Burden of Obstructive Sleep Apnea in Stroke (BOSAST) (NCT NCT00952211)

Results Overview

POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

10 days after beginning CPAP treatment

Results posted on

2016-04-04

Participant Flow

The study opened for enrollment on 9/16/09 at San Diego Rehabilitation Institute. Enrollment was halted in April 2011 and the study terminated due to low recruitment numbers.

Participant milestones

Participant milestones
Measure	CPAP CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime	Sub-therapeutic CPAP CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime
Overall Study STARTED	3	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Burden of Obstructive Sleep Apnea in Stroke (BOSAST)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CPAP n=3 Participants CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime	Sub-therapeutic CPAP CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 participants n=5 Participants	—	2 participants n=5 Participants
Age, Categorical >=65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Gender Female	2 participants n=5 Participants	—	2 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 days after beginning CPAP treatment

Population: Data only available for 2 subjects; one subject did not provide data for this questionnaire.

POMS fatigue subscale: 7 items; range 0-28; higher score indicates worse symptoms, i.e., more fatigue

Outcome measures

Outcome measures
Measure	CPAP n=2 Participants CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime	Sub-therapeutic CPAP CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime
Profile of Mood States (POMS) - Fatigue Subscale	10 units on a scale Standard Deviation 2.83	—

SECONDARY outcome

Timeframe: 10 days after beginning CPAP treatment

HADS depression subscale: 7 items, range 0-21. Higher score indicates worse symptoms

Outcome measures

Outcome measures
Measure	CPAP n=3 Participants CPAP at therapeutic pressure CPAP: CPAP at therapeutic pressure during nighttime	Sub-therapeutic CPAP CPAP administered at sub-therapeutic pressure CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime
Hospital Anxiety and Depression (HADS) Scale -Depression Subscale	8 units on a scale Standard Deviation 5	—

Adverse Events

CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sub-therapeutic CPAP

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

Dr. Joel Dimsdale

UCSD

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place