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

NCT07423988 | Recruiting DMC

• 2 other identifiers: RC31/24/0575ID-RCB
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Sleep Disorder (Disorder)

Keywords

sleep; high altitude; sleep disorder; cardiorespiratory parameters

Outcome Measures

Primary Outcomes (1)

• Comparison of sleep efficiency (total sleep time / total sleep period) under high altitude conditions (at 2877 m) versus without increased altitude (at home)

  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 Outcomes (5)

• 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"

  1 week after the inclusion

• Measurement of sleep parameters in low altitude conditions for the group "without on-call nights at high altitude"

  1 week after the inclusion

• Evaluation of the relationship between sleep quantification criteria and sleep disorder criteria

  1 week after the inclusion

• Correlation between cardiac parameters and sleep efficiency.

  1 week after the inclusion

• Comparison of sleep parameters, in conditions without increased altitude, between the 2 groups of participants

  1 week after the inclusion

Study Arms (2)

group with overnight on-call duty at high altitude at the Pic du Midi

EXPERIMENTAL

employees of the Pic du Midi who spend the night at high altitude

Other: Sleep recording

group without night duty at high altitude

ACTIVE COMPARATOR

employees of the Pic du Midi who spend the night at home in the plain

Other: Sleep recording

Interventions

Sleep recording OTHER

Polysomnography and questionnaires.

group with overnight on-call duty at high altitude at the Pic du Midi; group without night duty at high altitude

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Unité du sommeil, Hôpital Pierre Paul Riquet, 1 place du Docteur Baylac

Toulouse, Oui, 31059, France

RECRUITING

MeSH Terms

Conditions

Sleep Wake Disorders; Altitude Sickness

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Rachel DEBS, MD

CONTACT

05 61 77 94 88; debs.r@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 20, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)