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Clinical Trials/NCT07423988
NCT07423988
Recruiting
Not Applicable

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

University Hospital, Toulouse2 sites in 1 country32 target enrollmentStarted: March 23, 2026Last updated:
InterventionsSleep recording

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
32
Locations
2
Primary Endpoint
Comparison of sleep efficiency (total sleep time / total sleep period) under high altitude conditions (at 2877 m) versus without increased altitude (at home)

Overview

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..

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

Intervention: Sleep recording (Other)

group without night duty at high altitude

Active Comparator

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

Intervention: Sleep recording (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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