Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

Conditions
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Drug Induce Sleep Endoscopy, Hypnosis, Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate obstructive sleep apnea syndrome patient under hypnosis<br>Patients suffering from moderate obstructive sleep apnea syndrome. It is proposed to induce in the patient a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways. The type of collapsibility thus obtained, classified according to Kezirian (6), will allow specific management by OAM in the event of predominant anteroposterior stenosis. | Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis<br>* Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients for whom the DISE could be performed in good conditions of comfort | 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. | 45 days |