Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

It is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (VAS) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. The collapsibility type obtained, classified according to Kezirian, will allow specific management by OAM in the event of predominant anteroposterior stenosis. There are no risks fort the patient. The Drug Induce Sleep endoscopy (DISE) is a fibroscopy of upper aerodigestive tract.

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Key information

Conditions

Drug Induce Sleep Endoscopy Apnea Dyssomnias Hypnosis Nervous System Diseases Obstructive Sleep Apnea Syndrome Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre du Sommeil de la Polyclinique de Poitiers

Potiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient, women or men over 18 years old
Moderate obstructive sleep apnea syndrome (Hypopnea apnea index between 15 and 30) without any serious sign
Simple Ronchopathy
Indication of video-fibroscopy of upper airways
Affiliated subject or beneficiary of a social security scheme
Patient having signed the free and informed consent

Exclusion criteria

Psychiatric disorders that can be decompensated by hypnosis (bipolarity, schizophrenia, ...)
Smoking less than 10 cigarettes per day
Alcoholism, chronic or serious disabling pathology
Medical history of cancer of upper airways, radiotherapy
Pregnancy
Recent supper airway infection, rhinosinusitis
Active allergy
Non-obstructive sleep apnea syndrome
severe non-obstructive sleep apnea syndrome (Hypopnea apnea index> 30)
Dental contraindication to mandibular advancement device
Intolerance or allergy to local anesthesia with Xylocaine spray 5% known
Refusal to participate in the study
Protected patients: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Pregnant, breastfeeding or parturient woman
Hospitalized without consent

Treatment and study plan

Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis

Procedure

Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.

Primary outcomes

proportion of patients for whom the DISE could be performed in good conditions of comfort

Time frame: 45 days
The good conditions of comfort for the patient, the operator and the healthcare professional trained in hypnosis will be evaluated using a comfort scale with 4 subscales of 5 items, rated from 1 to 4, in Likert scale from 1 (not at all satisfied) to 4 (very satisfied), i.e. for each subscale a sub-score between 5 and 20 and an overall score between 20 and 80.
- Patient comfort
- Physical comfort (5 items)
- Psychological comfort (5 items)
- Practitioner comfort
o For the realization of the DISE (5 items)
- Comfort of the health professional trained in hypnosis o For the realization of hypnosis (5 items) It will be considered that the DISE could have been carried out in good conditions of comfort (for the patient, the operator and the healthcare professional trained in hypnosis), if the overall score is ≥60 AND no sub-score n 'is <10.

Sponsors and collaborators

Lead sponsor

Elsan

Other

Collaborators

European Clinical Trial Experts Network
Polyclinique Poitiers

Registry information

Acronym: DISE

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Oct 25, 2021
Registry last updated: Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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