The Different Diagnostic Values of Polysomnographies at Low and at Moderate Altitude - A Randomized Crossover Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- T90 (time spent in SpO2 below 90%)
Study Overview
Brief Summary
The purpose of this study is to investigate the effect of short-term descent in healthy residents at moderate altitude (>1000 m.a.s.l.).
Detailed Description
Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 590 m.a.s.l.) as well as for 2 consecutive nights at the participants home elevations (CH; >1000 m.a.s.l.). Between the measurements at those two different altitudes there will be a two-week washout period at >1000 m.a.s.l.. The sequence of altitude exposure will be randomized.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy (no current medical condition or intake of regular medication, except negligible medical issues or accidents not interfering with the current health status or physical performance.)
- •Living above 1000 m.a.s.l. since at least 1 year
- •No overnight stay at altitudes <1000 m.a.s.l. in the previous 4 weeks
- •18-70 years old
- •Body mass index 18,5-30 kg/m2
- •informed consent
Exclusion Criteria
- •Active diseases or health related conditions that require treatment (sleep disorders (mainly sleep apnea), chronic rhinitis, cardiovascular and lung diseases)
- •Use of drugs that affect the respiratory center drive (sedatives, sleep inducing drugs, opioids), stimulants or illegal drugs
- •Regular consumption of recreational drugs (alcohol and nicotine included)
Arms & Interventions
A
Polysomnographies will be done first for 2 nights at the sleep laboratory in Chur (590 m.a.s.l.) and after a two-week washout period for 2 nights at the participants home elevations (>1000 m.a.s.l.).
Intervention: Descent to low altitude (Diagnostic Test)
B
Polysomnographies will be done first for 2 nights at the participants home elevations (>1000 m.a.s.l.). and after a two-week washout period for 2 nights at sleep laboratory in Chur (590 m.a.s.l.).
Intervention: Descent to low altitude (Diagnostic Test)
Outcomes
Primary Outcomes
T90 (time spent in SpO2 below 90%)
Time Frame: 4 nights
T90 is the percent of sleeping time which the participant spent in SpO2 below 90%. It provides information about the duration and degree of hypoxia during the whole sleep.
Secondary Outcomes
- SWS (slow-wave sleep)(4 nights)
- AI (arousal index)(4 nights)
- TcCO2 (partial pressure of carbon dioxide)(4 nights)
- WASO (wakefulness after sleep onset)(4 nights)
- ODI (oxygen desaturation index)(4 nights)
- SpO2 (oxygen saturation)(4 nights)
- AHI (apnea-hypopnea index)(4 nights)
Investigators
Tsogyal Latshang
Head of Pneumology
Kantonsspital Graubünden