Sleep Longitudinal Exploration of the Experience of Patients

NCT ID: NCT06888427

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-23
• Study Completion Date: 2025-12-31

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.

Conditions

Sleep

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients requiring scheduled surgery with post-operative hospitalization

Patients will pass questionnaires to assess their postoperative sleep quality

Questionnaires

Intervention Type: OTHER

With the help of a questionnaires, determination of postoperative sleep quality

Interventions

Questionnaires

With the help of a questionnaires, determination of postoperative sleep quality

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Axel Maurice - Szamburski, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

CHU de Nice

Nice, Alpes-Maritimes, France

Site Status: RECRUITING

Countries

France

Central Contacts

Axel Maurice - Szamburski, MD-PhD

Role: CONTACT

maurice-szamburski.A@chu-nice.fr

+33492038130

Juliana Folgado

Role: CONTACT

folgado.j@chu-nice.fr

+33492038130

Facility Contacts

Axel MAURICE-SZAMBURSKI, MD, PhD

Role: primary

maurice-szamburski.a@chu-nice.fr

+33 4 92 03 81 30

Other Identifiers

24-PP-18

Identifier Type: -

Identifier Source: org_study_id