Sleep Longitudinal Exploration of the Experience of Patients

NCT06888427 | Recruiting

• 1 other identifier: 24-PP-18
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Keywords

sleep, surgical intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determination of Sleepiness

  Day 1 post-operative

• Determination of patient's perioperative satisfaction

  Day 1 post-operative

Study Arms (1)

Patients requiring scheduled surgery with post-operative hospitalization

Patients will pass questionnaires to assess their postoperative sleep quality

Other: Questionnaires

Interventions

Questionnaires OTHER

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

Patients requiring scheduled surgery with post-operative hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes-Maritimes, 06003, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Axel Maurice - Szamburski, MD-PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Maurice - Szamburski, MD-PhD

CONTACT

+33492038130; maurice-szamburski.A@chu-nice.fr

Juliana Folgado

CONTACT

+33492038130; folgado.j@chu-nice.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 21, 2025
• Study Start: April 23, 2025
• Primary Completion: October 23, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)