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Anesthetic Management of Patients With Chronic Sleep Disorders (ANEST-SLEEP)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Idiopathic Hypersomnia
Restless Legs Syndrome
Narcolepsy

Treatments

Other: Questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04827329
RECHMPL21_0192

Details and patient eligibility

About

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.

Full 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

Enrollment

700 patients

Sex

All

Ages

16 to 100 years old

Volunteers

No 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.

Exclusion criteria

  • less than 16 years old at time of the study

Trial design

700 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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