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OpenTrials
Completed

NCT Number: NCT04827329

Anesthetic Management of Patients With Chronic Sleep Disorders

The aim of this study is to describe and compare the anaesthesia history and possible problems encountered in 3 groups of patients with 3 chronic sleep diseases: narcolepsy, idiopathic hypersomnia, and restless legs syndrome followed at the Montpellier Sleep Unit.

For each participant, existing data from the medical record will be used, with their consent. All participants will complete a standardized questionnaire, concerning their history of anaesthesia, the course and possible complications, and questions about their treatment for their sleep disorder.

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Key information

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

This is both a retrospective and prospective single-center study. In the prospective part of the study, patients complete a self-questionnaire, with :

  • a non-specific part, concerning the history of anaesthesia (locoregional or general), the patient's feelings about these anaesthesias (possible difficulties in waking up, pain) and details about the the course of the anaesthesia (including possible complications).
  • a part specific to the sleep disease (possible rebound of symptoms, management of sleep treatments before and after anesthesia, sleep treatments before and after the different types of anesthesia).

Evaluation Criteria:

Main:

Frequency of history of locoregional and general anesthesia, and their possible complications.

Secondary:

Frequency of patients with rebound symptoms, or with worsening symptomatology (in each of the 3 groups, and in subgroups of patients with the same treatments), during locoregional and general anesthesia independently.

Other parameters collected via self-questionnaire (and at the time of the initial evaluation, retrospectively on medical records):

  • Sociodemographic data: age, gender, body mass index
  • Data related to the disease: age of onset of symptoms, age of diagnosis
  • Other associated medical conditions
  • Type of surgery
  • Type, date and the number of anesthesia: locoregional, general

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • men and women, more than 16 years old
  • diagnosed with a chronic sleep disorder including : Narcolepsy type 1, type 2, idiopathic hypersomnia, restless legs syndrome (diagnosis according to international criteria, ICSD-3, AASM, 2014).
  • followed at Monpellier Sleep Disorders Unit.

Exclusion criteria

  • less than 16 years old at time of the study

Treatment and study plan

Questionnaire

Other

Patients will complete a questionnaire regarding their anesthesia history, course and possible complications, and Questions about their treatment for their sleep disorder.

Primary outcomes

  1. Frequency of history of locoregional

    Time frame: 1 day

    Frequency of history of locoregional and general anesthesia, and their possible complications : change in frequency or complication of symptoms after a surgical procedure under general or locoregional anesthesia

Secondary outcomes

  1. Frequency of patients with rebound symptoms, or with worsening symptomatology

    Time frame: 1 day

    rebound of symptoms, occurrence of new symptoms or worsening of symptoms after a surgical procedure under general or locoregional anesthesia

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: ANEST-SLEEP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Sep 8, 2021

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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