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NCT Number: NCT06888427

Sleep Longitudinal Exploration of the Experience of Patients

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Determination of factors influencing sleep quality

    Time frame: Day 1 post-operative

    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).

Secondary outcomes

  1. Determination of Sleepiness

    Time frame: Day 1 post-operative

    The occurrence of drowsiness will be assessed using a single-choice question with 5 options (5: absence of drowsiness; 0 : presence of drowsiness)

  2. Determination of patient's perioperative satisfaction

    Time frame: Day 1 post-operative

    The perioperative patient' satisfaction assessed by the EVAN questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction (1-100 points)

Study contacts

Contact information is provided by the study sponsor or research team.

Axel Maurice - Szamburski, MD-PhD

CONTACT

[email protected]

+33492038130

Juliana Folgado

CONTACT

[email protected]

+33492038130

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Qualitative Analysis of Factors Affecting Perioperative Sleep Quality During Scheduled Surgery

Acronym: SLEEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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