Sleep Disorder (Disorder)ALTISOMNCT07423988
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
A study testing Sleep recording in people with Sleep Disorder (Disorder), run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder (Disorder)
- What is being tested?
- Sleep recording
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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":
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Unité du sommeil, Hôpital Pierre Paul Riquet, 1 place du Docteur Baylac
Toulouse, Oui, 31059
Emeline MULLER, 0561778707, muller.e@chu-toulouse.Fr
About this study
Official title: 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..
- Conditions
- Sleep Disorder (Disorder)
- Being tested
- Sleep recording
- Keywords
- sleep, high altitude, sleep disorder, cardiorespiratory parameters
- Medical subject headings
- Sleep Wake Disorders, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep recordingOther
Polysomnography and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Sleep recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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"
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.
Measured: 1 week after the inclusion
Measurement of sleep parameters in low altitude conditions for the group "without on-call nights at high altitude"
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.
Measured: 1 week after the inclusion
Evaluation of the relationship between sleep quantification criteria and sleep disorder criteria
Comparison of questionnaire responses and polysomnographic recording
Measured: 1 week after the inclusion
Correlation between cardiac parameters and sleep efficiency.
Correlation between heart rate variability and sleep efficiency using polysomnography recording
Measured: 1 week after the inclusion
Comparison of sleep parameters, in conditions without increased altitude, between the 2 groups of participants
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
Measured: 1 week after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start23 Mar 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423988
- Sponsor's protocol ID
- RC31/24/0575
- Other IDs
- ID-RCB
- Acronym
- ALTISOM
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07423988
- Acronym / sponsor ID
- ALTISOM / RC31/24/0575
- Conditions
- Sleep Disorder (Disorder)
- Keywords
- sleep, high altitude, sleep disorder, cardiorespiratory parameters
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with overnight on-call duty at high altitude at the Pic du Midi | Experimental | Other: Sleep recordingemployees of the Pic du Midi who spend the night at high altitude |
| group without night duty at high altitude | Active comparator | Other: Sleep recordingemployees of the Pic du Midi who spend the night at home in the plain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Employed at the Pic du Midi for at least one month
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep recordingPolysomnography and questionnaires. | Other | group with overnight on-call duty at high altitude at the Pic du Midi, group without night duty at high altitude |
Primary outcome
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.
5 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"
Time frame: 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
Evaluation of the relationship between sleep quantification criteria and sleep disorder criteria
Time frame: 1 week after the inclusion
Correlation between cardiac parameters and sleep efficiency.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep recording in people with Sleep Disorder (Disorder), run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel DEBS, MD (05 61 77 94 88 ext. + 33, debs.r@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.