Trial Outcomes & Findings for Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial. (NCT NCT01703663)

Results Overview

Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

night 1 and night 2

Results posted on

2016-10-13

Participant Flow

Some subjects were discharged from the hospital between the first and second night and therefore dropped out.

Participant milestones

Participant milestones
Measure	EPAP Therapy First Night, Then Control Night During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.	Control Night First Night, EPAP Therapy Second Night During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
First Treatment Period STARTED	20	20
First Treatment Period COMPLETED	20	20
First Treatment Period NOT COMPLETED	0	0
Second Treatment Period STARTED	11	8
Second Treatment Period COMPLETED	11	8
Second Treatment Period NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nasal EPAP for Stroke Patients With Sleep Apnea: a Pilot Trial.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=19 Participants
Age, Continuous	60 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Body mass index, self reported	29.1 kg/m^2 n=99 Participants
NIH Stroke Scale	4 units on a scale n=99 Participants

PRIMARY outcome

Timeframe: night 1 and night 2

Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas and divided by the hours of sleep based on actigraphy. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The prespecified primary (absolute) treatment effect is based on the linear repeated measures model.

Outcome measures

Outcome measures
Measure	EPAP Night n=19 Participants Raw data from EPAP night (not taking into account period effect).	Control Night n=19 Participants Raw data from control night (not taking into account period effect).
Apnea-hypopnea Index	17.1 apneas plus hypopneas per hour Interval 13.2 to 26.5	25.2 apneas plus hypopneas per hour Interval 14.2 to 49.6

Adverse Events

EPAP Night

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Night

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

Devin L. Brown, MD, MS

University of Michigan

Phone: 734-936-9075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place