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

Healthy Clinical Trial

Official title:

The Different Diagnostic Values of Polysomnographies at Low and at Moderate Altitude - A Randomized Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05826808
• Other study ID #: 2023-00636
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: February 2024

Study information

• Verified date: October 2023
• Source: Kantonsspital Graubünden
• Contact: Tsogyal Latshang
• Phone: +41812566339
• Email: tsogyal.latshang[@]ksgr.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Graubünden	Chur

Sponsors (1)

Lead Sponsor	Collaborator
Tsogyal Latshang

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SpO2 (oxygen saturation)	SpO2 is the amount of haemoglobin bound to oxygen. Normal values lie above 95%. Values below 90% are considered as low and require treatment.	4 nights
Secondary	AHI (apnea-hypopnea index)	AHI is defined as the number of apneas and hypopneas per hour of sleep, whereby apnea is defined as a cessation of the airflow for =10 seconds, while hypopnea is defined as a reduction of the airflow =30% with an oxygen desaturation =3% or an arousal.	4 nights
Secondary	SWS (slow-wave sleep)	SWS includes the deep sleep phase. Deep sleep is amongst other important for energy restoration, immune system strengthening and regeneration of cells.	4 nights
Secondary	AI (arousal index)	AI is the number of arousals per hour of sleep, whereby an arousal is an interruption of sleep from 3-15 seconds. They prevent suffocation in the sleep apnea by interrupting breathing pauses but are also coupled with a lot of stress for the human body.	4 nights
Secondary	TcCO2 (partial pressure of carbon dioxide)	TcCO2 correlates with PaCO2 and is therefore a non-invasive alternative. A normal value of PCO2 lies between 35 and 45 mmHg. Lower values can lead to muscle cramps, abnormal heartbeat and much more.	4 nights
Secondary	WASO (wakefulness after sleep onset)	WASO is the time spent awake after sleep onset. High values of WASO are for example found in sleep apnea, insomnia and restless leg syndrome.	4 nights
Secondary	ODI (oxygen desaturation index)	ODI is defined as the number of oxygen decreases =3% per hour of sleep.	4 nights