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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01842906
• Date of registration: 22/04/2013
• Prospective Registration: Yes
• Primary sponsor: Stanford University
• Public title: Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID) SLEEP-AID
• Scientific title: Randomized Controlled Trial for Assessment of a Novel Non-Pharmacologic Intervention for Decrease in Altitude Illness
• Date of first enrolment: October 2013
• Target sample size: 219
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01842906
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Nepal

Contacts

• Name: Grant S Lipman, MD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

Inclusion Criteria:

- ages 18-65

- Lake Louise Score (LLS) of < 3

- Have not taken NSAIDs, acetazolamide, or corticosteroids in the prior week

- Have not traveled above 4200 m in the prior week.

- First night in Pheriche or Dingboche

Exclusion Criteria:

- Unable to read the consent form

- Taken NSAIDs, acetazolamide, or corticosteroids in the week prior to study enrollment.

- Hazardous medical conditions which precludes the ability to tolerate the experimental
device.

- Pregnancy or suspected pregnancy.

- Participants who are younger than 18 years of age and more than 65.

- Travel to or above 4200m in the preceding week.

- Diagnosis of AMS upon enrollment (LLS =3 with symptoms of headache)

- Previously diagnosed obstructive sleep apnea

- Current symptoms of nasal congestion, rhinorrhea, sinusitis, upper respiratory
infection, asthma, COPD exacerbation, pneumonia, bronchitis, or other disease of the
respiratory tract.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Mountain Sickness

Intervention(s)

Device: Control

Device: Theravent

Primary Outcome(s)

Incidence of Acute Mountain Sickness [Time Frame: Approximately 10 hours]

Secondary Outcome(s)

Number of Nocturnal Desaturations [Time Frame: Approximately 10 hours]

Nocturnal Awakenings [Time Frame: approximately 10 hours]

Acute Mountain Sickness Severity [Time Frame: approximately 10 hours]

Secondary ID(s)

SLEEP-AID

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Utah

Results

• Results available: Yes
• Date Posted: 20/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01842906