ANEST-SLEEP: Anesthetic Management of Patients With Chronic Sleep Disorders

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04827329

Collaborator

(none)

700

Enrollment

Location

Actual Duration (Months)

174.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcolepsy Idiopathic Hypersomnia Restless Legs Syndrome	Other: Questionnaire

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 Design

Study Type:

Observational

Actual Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Anesthetic Management of Patients With Chronic Sleep Disorders

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Patients with a sleep disorder Patients with a sleep disorder recording performed in the Sleep Unit in Montpellier University Hospital.	Other: Questionnaire Patients will complete a questionnaire regarding their anesthesia history, course and possible complications, and Questions about their treatment for their sleep disorder.
Patients with a narcolepsy Patients with a narcolepsy (type 1 or type 2) / a idiopathic hypersomnia or a restless legs syndrome.	Other: Questionnaire Patients will complete a questionnaire regarding their anesthesia history, course and possible complications, and Questions about their treatment for their sleep disorder.

Arm

Intervention/Treatment

Patients with a sleep disorder

Patients with a sleep disorder recording performed in the Sleep Unit in Montpellier University Hospital.

Other: Questionnaire

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

Patients with a narcolepsy

Patients with a narcolepsy (type 1 or type 2) / a idiopathic hypersomnia or a restless legs syndrome.

Other: Questionnaire

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.