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Sleep Longitudinal Exploration of the Experience of Patients

Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06888427
Acronym
SLEEP
Enrollment
1000
Registered
2025-03-21
Start date
2025-04-23
Completion date
2026-12-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Keywords

sleep, surgical intervention

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.

Interventions

OTHERQuestionnaires

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

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination of factors influencing sleep qualityDay 1 post-operativeSleep 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

MeasureTime frameDescription
Determination of SleepinessDay 1 post-operativeThe 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 satisfactionDay 1 post-operativeThe perioperative patient' satisfaction assessed by the EVAN questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction (1-100 points)

Countries

France

Contacts

CONTACTAxel Maurice - Szamburski, MD-PhD
maurice-szamburski.A@chu-nice.fr+33492038130
CONTACTJuliana Folgado
folgado.j@chu-nice.fr+33492038130
PRINCIPAL_INVESTIGATORAxel Maurice - Szamburski, MD-PhD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026