NCT01842906

Brief Summary

The study is examining if an over-the-counter device (Theravent) worn while sleeping can reduce acute mountain sickness upon awakening in a high altitude trekking population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 20, 2017

Completed
Last Updated

December 13, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

April 22, 2013

Results QC Date

August 9, 2016

Last Update Submit

November 21, 2018

Conditions

Acute Mountain Sickness

Keywords

positive end expiratory pressureacute mountain sicknesspreventionhigh altitude

Outcome Measures

Primary Outcomes (1)

  • Incidence of Acute Mountain Sickness

    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.

    Approximately 10 hours

Secondary Outcomes (3)

  • Number of Nocturnal Desaturations

    Approximately 10 hours

  • Acute Mountain Sickness Severity

    approximately 10 hours

  • Nocturnal Awakenings

    approximately 10 hours

Study Arms (2)

Theravent

EXPERIMENTAL

A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.

Device: Theravent

Control

SHAM COMPARATOR

A visibly identical sham device that does not provide positive end expiratory pressure.

Device: Control

Interventions

TheraventDEVICE

nasal EPAP device

Theravent
ControlDEVICE

Sham device without EPAP

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nepal

Pheriche & Dingboche, Khumbu, Nepal

Location

Related Publications (1)

  • Lipman GS, Kanaan NC, Phillips C, Pomeranz D, Cain P, Fontes K, Higbee B, Meyer C, Shaheen M, Wentworth S, Walsh D. Study Looking at End Expiratory Pressure for Altitude Illness Decrease (SLEEP-AID). High Alt Med Biol. 2015 Jun;16(2):154-61. doi: 10.1089/ham.2014.1110. Epub 2015 May 7.

    PMID: 25950723RESULT

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Grant Lipman
Organization
Stanford Department of Emergency Medicine
gslipman@stanford.edu
415-290-9286

Study Officials

  • Grant S Lipman, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 30, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

October 1, 2014

Last Updated

December 13, 2018

Results First Posted

April 20, 2017

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)