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

September 6, 2021 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UHMontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of history of locoregional
Time Frame: 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
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of patients with rebound symptoms, or with worsening symptomatology
Time Frame: 1 day
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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