Clinical trial NCT04827329: Anesthetic Management of Patients With Chronic Sleep Disorders
Official title: Anesthetic Management of Patients With Chronic Sleep Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy
Idiopathic Hypersomnia
Restless Legs Syndrome
Keywords: Sleep
Anesthesia
Sedation
Surgery
drugs
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 700
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of history of locoregional
timeFrame: 1 day
Secondary outcomes:
measure: Frequency of patients with rebound symptoms, or with worsening symptomatology
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yves DAUVILLIERS, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.