Effect of Short-term Descent to Low Altitude in Healthy Residents at Moderate Altitude (>1000 m.a.s.l.).

NCT05826808 | Completed

• 1 other identifier: 2023-00636
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• T90 (time spent in SpO2 below 90%)

  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.

  4 nights

Secondary Outcomes (7)

• SpO2 (oxygen saturation)

  4 nights

• AHI (apnea-hypopnea index)

  4 nights

• SWS (slow-wave sleep)

  4 nights

• AI (arousal index)

  4 nights

• TcCO2 (partial pressure of carbon dioxide)

  4 nights

Study Arms (2)

A

EXPERIMENTAL

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.).

Diagnostic Test: Descent to low altitude

B

EXPERIMENTAL

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.).

Diagnostic Test: Descent to low altitude

Interventions

Descent to low altitude DIAGNOSTIC_TEST

The polysomnographic recordings include electroencephalogram (EEG), electrooculogram (EOG), electromyogram (EMG), electrocardiogram (ECG), pulse oximetry, transcutaneous capnography, nasal airflow and thoracic and abdominal respiratory effort.

A; B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old
• Body mass index 18,5-30 kg/m2
• informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tsogyal Latshang: lead

Study Sites (1)

Kantonsspital Graubünden

Chur, Switzerland

Location

Study Officials

• Tsogyal Latshang, PD Dr. med.

  Kantonsspital Graubünden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Pneumology

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 24, 2023
• Study Start: June 30, 2023
• Primary Completion: March 16, 2024
• Study Completion: March 16, 2024
• Last Updated: February 18, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)