Sleep Longitudinal Exploration of the Experience of Patients (SLEEP)

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.

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 Overview

• Status: Recruiting
• Conditions: Sleep
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Axel Maurice - Szamburski, MD-PhD; Phone Number: +33492038130; Email: maurice-szamburski.A@chu-nice.fr
• Study Contact Backup: Name: Juliana Folgado; Phone Number: +33492038130; Email: folgado.j@chu-nice.fr

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06003
      • Recruiting
      • CHU de Nice
      • Contact: Axel MAURICE-SZAMBURSKI, MD, PhD; Phone Number: +33 4 92 03 81 30; Email: maurice-szamburski.a@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients older thant 18 requiring scheduled surgery with post-operative hospitalization

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring scheduled surgery with post-operative hospitalization; Patients will pass questionnaires to assess their postoperative sleep quality	Other: Questionnaires; With the help of a questionnaires, determination of postoperative sleep quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1 post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Day 1 post-operative

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Axel Maurice - Szamburski, MD-PhD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: sleep, surgical intervention
• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 24-PP-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No