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

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome; Narcolepsy; Idiopathic Hypersomnia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients, older than 16 years at time of the study, diagnosed with a sleep disorder: narcolepsy (1 or 2), idiopathic hypersomnia and restless legs syndrome.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of history of locoregional	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	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients with rebound symptoms, or with worsening symptomatology	rebound of symptoms, occurrence of new symptoms or worsening of symptoms after a surgical procedure under general or locoregional anesthesia	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Publications and helpful links

General Publications

• Hershner S, Kakkar R, Chung F, Singh M, Wong J, Auckley D. Narcolepsy, Anesthesia, and Sedation: A Survey of the Perioperative Experience of Patients With Narcolepsy. Anesth Analg. 2019 Nov;129(5):1374-1380. doi: 10.1213/ANE.0000000000003954.
• Hershner S, Dauvilliers Y, Chung F, Singh M, Wong J, Gali B, Kakkar R, Mignot E, Thorpy M, Auckley D. Knowledge Gaps in the Perioperative Management of Adults With Narcolepsy: A Call for Further Research. Anesth Analg. 2019 Jul;129(1):204-211. doi: 10.1213/ANE.0000000000004088.
• Ohshita N, Yamagata K, Himejima A, Kaneda K, Yasutome T, Matsuda Y, Tsutsumi YM, Momota Y. Anesthetic Management of a Patient With Restless Legs Syndrome: A Case Report. Anesth Prog. 2020 Dec 1;67(4):226-229. doi: 10.2344/anpr-67-02-10.
• Raux M, Karroum EG, Arnulf I. Case scenario: anesthetic implications of restless legs syndrome. Anesthesiology. 2010 Jun;112(6):1511-7. doi: 10.1097/ALN.0b013e3181de2d66. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): June 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 6, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Surgery; Sleep; Sedation; Anesthesia; drugs
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Sleep Wake Disorders; Restless Legs Syndrome; Parasomnias; Disorders of Excessive Somnolence; Narcolepsy; Idiopathic Hypersomnia
• Other Study ID Numbers: RECHMPL21_0192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No