- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423988
Evaluation of Changes in Sleep Efficiency Among PIC DU MIDI Staff Between Nights Spent at Home and Nights Spent in the Workplace Under High Altitude Conditions (ALTISOM)
April 7, 2026 updated by: University Hospital, Toulouse
Evaluation of Changes in Sleep Efficiency Among PIC DU MIDI Employees Between Nights Spent at Home (Without Increased Altitude) and Nights Spent in a Professional Environment Under High Altitude Conditions
Sleep organization and cardiorespiratory parameters are disrupted in extreme conditions such as high altitude.
The pathophysiology of medical problems related to acute high-altitude exposure is partially understood, but sleep quality indicators are very rarely measured under these conditions.
This lack of information is even more pronounced among employees subjected to cyclical exposure to high-altitude hypoxic stress, as is the case for the employees at the Pic du Midi.
These 32 employees regularly report to their occupational physician difficulties in managing their sleep disorders, struggling to distinguish symptoms from objective changes in their sleep cycles.
Among them, 13 are on call at the summit of the Pic du Midi (2,877 m), while 19 work there during the day and return home to a lower altitude at night to sleep.
The investigators also wish to measure structural changes in sleep and its cardiorespiratory parameters using polysomnography in these 13 employees, comparing nights spent at home at normal altitude with those spent at the summit of the Pic du Midi.
These changes will also be compared to those of a group of 19 employees who do not sleep at high altitude..
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rachel DEBS, MD
- Phone Number: + 33 05 61 77 94 88
- Email: debs.r@chu-toulouse.fr
Study Locations
-
-
Oui
-
Toulouse, Oui, France, 31059
- Recruiting
- Unité du sommeil, Hôpital Pierre Paul Riquet, 1 place du Docteur Baylac
-
Contact:
- Emeline MULLER
- Phone Number: 0561778707
- Email: muller.e@chu-toulouse.Fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Group "with on-call night at high altitude at the Pic du Midi":
- Employed at the Pic du Midi for at least one month
- Working nights at high altitude (at the Pic du Midi, altitude of 2877m) as part of their professional activity
- Person affiliated with or covered by a social security scheme
- Free, informed, and written consent signed by the participant and the investigator
Night group "without on-call night at high altitude":
- Employed at the Pic du Midi for at least one month
- Not working nights at high altitude (at the Pic du Midi, altitude of 2877m) as part of their professional activity
- Person affiliated with or covered by a social security scheme social
- Free, informed and written consent signed by the participant and the investigator
Exclusion Criteria:
- For all participants:
- History of cardiovascular disease
- Use of cardiovascular/psychotropic medication
- Participant under legal guardianship or other protective regime (guardianship, curatorship)
- Pregnant or breastfeeding woman
- French language proficiency insufficient to complete the questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group with overnight on-call duty at high altitude at the Pic du Midi
employees of the Pic du Midi who spend the night at high altitude
|
Polysomnography and questionnaires.
|
|
Active Comparator: group without night duty at high altitude
employees of the Pic du Midi who spend the night at home in the plain
|
Polysomnography and questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of sleep efficiency (total sleep time / total sleep period) under high altitude conditions (at 2877 m) versus without increased altitude (at home)
Time Frame: 1 week after the inclusion
|
Sleep efficiency will be compared, according to the ratio = total sleep time (TST)/ total sleep period (PTS) calculated from a polysomnographic recording, between the night spent at high altitude (2877m, at PIC du MIDI) and the second night spent at home (not increased altitude) among PIC du MIDI employees performing on-call nights at high altitude.
|
1 week after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of sleep parameters in high altitude conditions versus without increased altitude for the group "with on-call night at high altitude at Pic du Midi"
Time Frame: 1 week after the inclusion
|
Sleep parameters (determined according to the criteria of the American Academy of Sleep Medicine (AASM)) measured from a polysomnographic recording will be compared in high altitude conditions versus without increased altitude.
|
1 week after the inclusion
|
|
Measurement of sleep parameters in low altitude conditions for the group "without on-call nights at high altitude"
Time Frame: 1 week after the inclusion
|
Sleep parameters (determined according to the criteria of the American Academy of Sleep Medicine (AASM)) will be measured from a polysomnographic recording under conditions without altitude gain.
|
1 week after the inclusion
|
|
Evaluation of the relationship between sleep quantification criteria and sleep disorder criteria
Time Frame: 1 week after the inclusion
|
Comparison of questionnaire responses and polysomnographic recording
|
1 week after the inclusion
|
|
Correlation between cardiac parameters and sleep efficiency.
Time Frame: 1 week after the inclusion
|
Correlation between heart rate variability and sleep efficiency using polysomnography recording
|
1 week after the inclusion
|
|
Comparison of sleep parameters, in conditions without increased altitude, between the 2 groups of participants
Time Frame: 1 week after the inclusion
|
Comparison of sleep parameters (determined according to the criteria of the American Academy of Sleep Medicine (AASM)) from the polysomnography recording between the two groups in conditions without increased altitude
|
1 week after the inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 28, 2027
Study Registration Dates
First Submitted
January 8, 2026
First Submitted That Met QC Criteria
February 13, 2026
First Posted (Actual)
February 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
April 7, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/24/0575
- ID-RCB (Other Identifier: 2026-A00289-42)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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