Strategies for rapid acclimatization to high altitude – using different modalities
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Incidence of Acute Mountain Sickness
Study Overview
Brief Summary
Exposure at high altitude (HA) induced hypobaric hypoxia is known to deteriorate health and decrease performance. The aim of the study is to develop of Rapid Acclimatization Schedule for HighAltitude in Western sector using different modalities. 400 volunteers within the age range of 20-40 years will be recruited. The volunteers will be randomized into 4 different groups - Control, Drug treated (Acetazolamide), Stay at Moderate Altitude (Short duration) and Intermittent Hypoxia Exposure (IHE). After recording their baseline parameters at Sea Level area they will be inducted to Stage - I HA by air followed by Stage - II HA by road. In all stages differentphysiological, physical and biochemical parameters would be assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •a) Age group: 20 – 40 years b) Medical history: SHAPE – I.
Exclusion Criteria
- •a) Smokers b) Drinker c) Prior induction to HA d) Medical history of any sort.
Outcomes
Primary Outcomes
Incidence of Acute Mountain Sickness
Time Frame: During the initial days after ascent to high altitude area.
Secondary Outcomes
- Exercise Capacity at High Altitude(After 48 and 72 hours after reaching high altitude area.)