Clinical trial NCT06888427: Sleep Longitudinal Exploration of the Experience of Patients
Official title: Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep
Keywords: sleep, surgical intervention
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older thant 18 requiring scheduled surgery with post-operative hospitalization

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determination of factors influencing sleep quality
timeFrame: Day 1 post-operative
Secondary outcomes:
measure: Determination of Sleepiness
timeFrame: Day 1 post-operative
measure: Determination of patient's perioperative satisfaction
timeFrame: Day 1 post-operative
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Axel Maurice - Szamburski, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: