Sleep Longitudinal Exploration of the Experience of Patients

Recruiting

• Conditions: Sleep

• Registration Number: NCT06888427
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-21
• Status Verified: 2025-04
• Study Start: 2025-04-23
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-10-23
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of factors influencing sleep quality	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).

Secondary Outcome Measures

Name	Time	Method
Determination of Sleepiness	Day 1 post-operative	The occurrence of drowsiness will be assessed using a single-choice question with 5 options (5: absence of drowsiness; 0 : presence of drowsiness)
Determination of patient's perioperative satisfaction	Day 1 post-operative	The perioperative patient' satisfaction assessed by the EVAN questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction (1-100 points)

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, Alpes-Maritimes, France