SleepSLEEPNCT06888427
Sleep Longitudinal Exploration of the Experience of Patients
An observational study of Sleep, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Questionnaires
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2025to Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older thant 18 requiring scheduled surgery with post-operative hospitalization
Who may be able to join
- Male or female subject aged 18 years or older;
- Subject scheduled to undergo surgery under general anesthesia (orthopedic, thoracic, vascular or visceral surgery);
- Subject able to complete a self-administered questionnaire;
- Subject having given oral consent;
Who cannot join
- Subject wishing to discontinue participation in the study before the end;
- Subject for whom the surgical procedure could not be performed after admission to the operating room (whatever the reason);
- Subject for whom the surgical procedure was performed urgently before the date initially scheduled (whatever the reason);
- Subject for whom a serious perioperative complication occurred during the surgical procedure
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
CHU de Nice
Nice, Alpes-Maritimes, 06003
Axel MAURICE-SZAMBURSKI, MD, PhD, +33 4 92 03 81 30, maurice-szamburski.a@chu-nice.fr
About this study
Official title: Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery
Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Postoperatively, it seems to be altered by pain, the ambient environment and night care.
Literature shows that the occurrence of post-operative sleep disorders seems to lead to (increased) hypnotic consumption in patients who did not consume them in the pre-operative phase with known risks of dependence.
Read more
Nowadays , general anesthesia is widely practiced worldwide. However, despite continuous improvement in techniques, a large number of patients still experience poor quality postoperative sleep, even with short-term anesthesia.
It therefore appears that general anesthesia disrupts the circadian rhythm of patients, even if the mechanisms are still poorly understood.
Thus, sleep deprivation could be responsible of physiological alterations that are still unknown, such as delayed healing or impaired respiratory muscle performance, promoting postoperative complications.
The aim of this study is to identify the factors impacting the quality of sleep of patients undergoing scheduled surgery during the first postoperative night. And its implication on the occurrence of drowsiness described by the patient the day after their surgical intervention.
- Conditions
- Sleep
- Being tested
- Questionnaires
- Keywords
- sleep, surgical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
With the help of a questionnaires, determination of postoperative sleep quality
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring scheduled surgery with post-operative hospitalization | Patients will pass questionnaires to assess their postoperative sleep quality Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of factors influencing sleep quality
Sleep quality will be assessed using a self-questionnaire called Spiegel. It includes 3 items assessing sleep with a gradation from 0 to 5. An overall score is calculated, ranging from 0 (worst possible experience) to 15 (very good quality of sleep).
Measured: Day 1 post-operative
Secondary outcomes (2)
Determination of Sleepiness
The occurrence of drowsiness will be assessed using a single-choice question with 5 options (5: absence of drowsiness; 0 : presence of drowsiness)
Measured: Day 1 post-operative
Determination of patient's perioperative satisfaction
The perioperative patient' satisfaction assessed by the EVAN questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction (1-100 points)
Measured: Day 1 post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start23 Apr 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Maurice - Szamburski, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888427
- Sponsor's protocol ID
- 24-PP-18
- Acronym
- SLEEP
- Status last verified
- May 2026
- First submitted
- 13 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery
- ClinicalTrials.gov ID
- NCT06888427
- Acronym / sponsor ID
- SLEEP / 24-PP-18
- Conditions
- Sleep
- Keywords
- sleep, surgical intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Mar 2025 (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.
Many epidemiological studies report that insomnia is common after fifty years in the general population but also in the post-operative period of surgery. Preoperatively, sleep quality can be disturbed by fear of general anesthesia and surgery. Postoperatively, it seems to be altered by pain, the ambient environment and night care.
Literature shows that the occurrence of post-operative sleep disorders seems to lead to (increased) hypnotic consumption in patients who did not consume them in the pre-operative phase with known risks of dependence.
Nowadays , general anesthesia is widely practiced worldwide. However, despite continuous improvement in techniques, a large number of patients still experience poor quality postoperative sleep, even with short-term anesthesia.
It therefore appears that general anesthesia disrupts the circadian rhythm of patients, even if the mechanisms are still poorly understood.
Thus, sleep deprivation could be responsible of physiological alterations that are still unknown, such as delayed healing or impaired respiratory muscle performance, promoting postoperative complications.
The aim of this study is to identify the factors impacting the quality of sleep of patients undergoing scheduled surgery during the first postoperative night. And its implication on the occurrence of drowsiness described by the patient the day after their surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring scheduled surgery with post-operative hospitalization | – | Other: QuestionnairesPatients will pass questionnaires to assess their postoperative sleep quality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older thant 18 requiring scheduled surgery with post-operative hospitalization
Key inclusion criteria (4 listed)
- Male or female subject aged 18 years or older;
- Subject scheduled to undergo surgery under general anesthesia (orthopedic, thoracic, vascular or visceral surgery);
- Subject able to complete a self-administered questionnaire;
- Subject having given oral consent;
Key exclusion criteria (4 listed)
- Subject wishing to discontinue participation in the study before the end;
- Subject for whom the surgical procedure could not be performed after admission to the operating room (whatever the reason);
- Subject for whom the surgical procedure was performed urgently before the date initially scheduled (whatever the reason);
- Subject for whom a serious perioperative complication occurred during the surgical procedure
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 |
|---|---|---|
| QuestionnairesWith the help of a questionnaires, determination of postoperative sleep quality | Other | Patients requiring scheduled surgery with post-operative hospitalization |
Primary outcome
Determination of factors influencing sleep quality
Time frame: Day 1 post-operative
Sleep quality will be assessed using a self-questionnaire called Spiegel. It includes 3 items assessing sleep with a gradation from 0 to 5. An overall score is calculated, ranging from 0 (worst possible experience) to 15 (very good quality of sleep).
2 secondary outcomes
Determination of Sleepiness
Time frame: Day 1 post-operative
Determination of patient's perioperative satisfaction
Time frame: Day 1 post-operative
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 22 May 2026.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Axel Maurice - Szamburski, MD-PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 4 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 22 May 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 Axel Maurice - Szamburski, MD-PhD (+33492038130, maurice-szamburski.A@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of factors influencing sleep quality (time frame: Day 1 post-operative). 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 22 May 2026.