Effects of +30° upper body head up tilt during sleep at genuine altitude on acute mountain sickness severity

Not Applicable

• Conditions: T70.2; G47.9; Other and unspecified effects of high altitude; Sleep disorder, unspecified

• Registration Number: DRKS00012676
• Lead Sponsor: Deutsches Zentrum für Luft- und Raumfahrt (DLR), Institut für Luft- und Raumfahrtmedizin, Abteilung Kardiovaskuläre Luft- und Raumfahrtmedizin (KLM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Study Completion: 2019-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

women and men = 18 and = 70 years of Age
- active ascent to the Capanna Regina Margherita preferably via the normal route starting from Alagna with overnight stay at the Capanna Gnifetti
- Lake Louise score = 3 and = 12 pts. after overnight sleep at the Capanna Gnifetti
To be included into the observational study arm no minimal Lake Louise score after overnight sleep at the Capanna Gnifetti is required.

Exclusion Criteria

- Candidates presenting no acute mountain sickness (Lake Louise Score < 3)
- Candidates presenting severe acute mountain sickness (Lake Louise Score > 12)
- Subjects that fulfil the exclusion criterion LLS < 3 pts. but want to continue the study will be transferred to the observational study arm
- Subjects presenting LLS = 12 pts. will be excluded in any case.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to end of the first night at 4554 m in: AMS-C score. The AMS-C score is determined by an 11-item questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change from baseline to end of the first night at 4554 m in: Sleep Quality. Sleep quality is determined by a 6 items questionnaire. Each item is evaluated by a visual analog scale (VAS).