Anesthetic Management of Patients With Chronic Sleep Disorders

Completed

• Conditions: Idiopathic Hypersomnia; Narcolepsy; Restless Legs Syndrome
• Interventions: Other: Questionnaire

• Registration Number: NCT04827329
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with a narcolepsy	Questionnaire	Patients with a narcolepsy (type 1 or type 2) / a idiopathic hypersomnia or a restless legs syndrome.
Patients with a sleep disorder	Questionnaire	Patients with a sleep disorder recording performed in the Sleep Unit in Montpellier University Hospital.

Primary Outcome Measures

Name	Time	Method
Frequency of history of locoregional	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 Outcome Measures

Name	Time	Method
Frequency of patients with rebound symptoms, or with worsening symptomatology	1 day	rebound of symptoms, occurrence of new symptoms or worsening of symptoms after a surgical procedure under general or locoregional anesthesia

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France