Effect of Moderate Altitude (>1000 m.a.s.l.) on Sleep Examinations (Polysomnography).

NCT ID: NCT05826808

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-03-16

Brief Summary

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The purpose of this study is to investigate the effect of moderate altitude (\>1000 m.a.s.l.) on sleep examinations (polysomnography).

Detailed Description

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Polysomnographies will be done for each participant for 2 consecutive nights at the sleep laboratory in Chur (CH; 600 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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Polysomnographies will be done first for 2 nights at the sleep laboratory in Chur (600 m.a.s.l.) and after a two-week washout period for 2 nights at the participants home elevations (\>1000 m.a.s.l.).

Group Type EXPERIMENTAL

Polysomnography

Intervention Type 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.

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 (600 m.a.s.l.).

Group Type EXPERIMENTAL

Polysomnography

Intervention Type 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.

Interventions

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Polysomnography

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tsogyal Latshang

OTHER

Sponsor Role lead

Responsible Party

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Tsogyal Latshang

Head of Pneumology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tsogyal Latshang, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Graubünden

Locations

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Kantonsspital Graubünden

Chur, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2023-00636

Identifier Type: -

Identifier Source: org_study_id

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