Trial Outcomes & Findings for Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID) (NCT NCT01842906)

Results Overview

Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC \> or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

219 participants

Primary outcome timeframe

Approximately 10 hours

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Theravent A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device	Control A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP
Overall Study STARTED	115	104
Overall Study COMPLETED	115	104
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Theravent n=115 Participants A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device	Control n=104 Participants A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP	Total n=219 Participants Total of all reporting groups
Age, Continuous	39 years STANDARD_DEVIATION 6 • n=5 Participants	37 years STANDARD_DEVIATION 8 • n=7 Participants	38 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	73 Participants n=7 Participants	156 Participants n=5 Participants
Region of Enrollment Nepal	115 participants n=5 Participants	104 participants n=7 Participants	219 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 10 hours

Acute mountain sickness will be measured by Lake Louise Criteria and diagnosed as LLC \> or = to 3 with presence of a headache. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.

Outcome measures

Outcome measures
Measure	Control n=104 Participants A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP	Theravent n=115 Participants A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device
Incidence of Acute Mountain Sickness	18 Participants	16 Participants

SECONDARY outcome

Timeframe: Approximately 10 hours

Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.

Outcome measures

Outcome measures
Measure	Control n=104 Participants A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP	Theravent n=115 Participants A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device
Number of Nocturnal Desaturations	270 Number of events Standard Deviation 226	214 Number of events Standard Deviation 183

SECONDARY outcome

Timeframe: approximately 10 hours

Population: Severity

Severity of acute mountain sickness will be evaluated by the Lake Louise Criteria (0-15 point scale) with higher scores representing more severe symptoms. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.

Outcome measures

Outcome measures
Measure	Control n=104 Participants A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP	Theravent n=115 Participants A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device
Acute Mountain Sickness Severity Dizziness severity	0.15 unit on a scale Interval 0.0 to 1.0	0.049 unit on a scale Interval 0.0 to 1.0
Acute Mountain Sickness Severity Sleep severity	1.11 unit on a scale Interval 0.0 to 3.0	1.13 unit on a scale Interval 0.0 to 3.0
Acute Mountain Sickness Severity Headache severity	0.46 unit on a scale Interval 0.0 to 3.0	0.26 unit on a scale Interval 0.0 to 3.0
Acute Mountain Sickness Severity Fatigue severity	0.15 unit on a scale Interval 0.0 to 2.0	0.20 unit on a scale Interval 0.0 to 2.0
Acute Mountain Sickness Severity Gastrointestinal symptoms severity	0.11 unit on a scale Interval 0.0 to 1.0	0.058 unit on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: approximately 10 hours

Number of nocturnal desaturations will be measured by Watch-PAT200, a wristwatch type continuous sleep cycle and pulse oximetry analyzer. Study participants will be followed approximately for 10 hours, from when they go to sleep until awakening the next morning.

Outcome measures

Outcome measures
Measure	Control n=104 Participants A visibly identical sham device that does not provide positive end expiratory pressure. Control: Sham device without EPAP	Theravent n=115 Participants A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping. Theravent: nasal EPAP device
Nocturnal Awakenings	11 Number of events Interval 6.0 to 14.0	13 Number of events Interval 7.0 to 18.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Theravent

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. Grant Lipman

Stanford Department of Emergency Medicine

Phone: 415-290-9286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place