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

Официальное название

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

Обзор

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..

Вмешательства

• Другое Sleep recording
  Polysomnography and questionnaires.

Первичные конечные точки

• Comparison of sleep efficiency (total sleep time / total sleep period) under high altitude conditions (at 2877 m) versus without increased altitude (at home) [Срок оценки: 1 week after the inclusion]

Вторичные конечные точки (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" [Срок оценки: 1 week after the inclusion]
• Measurement of sleep parameters in low altitude conditions for the group "without on-call nights at high altitude" [Срок оценки: 1 week after the inclusion]
• Evaluation of the relationship between sleep quantification criteria and sleep disorder criteria [Срок оценки: 1 week after the inclusion]
• Correlation between cardiac parameters and sleep efficiency. [Срок оценки: 1 week after the inclusion]
• Comparison of sleep parameters, in conditions without increased altitude, between the 2 groups of participants [Срок оценки: 1 week after the inclusion]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

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

Идентификаторы

NCT: NCT07423988 · RC31/24/0575 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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