Menu
Recruiting NCT06888427

Sleep Longitudinal Exploration of the Experience of Patients

Observational Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery

Overview

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

  • Other Questionnaires
    With the help of a questionnaires, determination of postoperative sleep quality

Primary outcome measures

  • Determination of factors influencing sleep quality [Time frame: Day 1 post-operative]
Secondary outcome measures (2)
  • Determination of Sleepiness [Time frame: Day 1 post-operative]
  • Determination of patient's perioperative satisfaction [Time frame: Day 1 post-operative]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT06888427 · 24-PP-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗