Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

NCT05091164 | Completed

• 1 other identifier: 2020-A02419-30
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Induce Sleep Endoscopy; Hypnosis; Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Moderate obstructive sleep apnea syndrome patient under hypnosis

EXPERIMENTAL

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

Interventions

Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis PROCEDURE

Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.

Moderate obstructive sleep apnea syndrome patient under hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead
• European Clinical Trial Experts Network: collaborator
• Polyclinique Poitiers: collaborator

Study Sites (1)

Centre du Sommeil de la Polyclinique de Poitiers

Potiers, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 25, 2021
• Study Start: February 8, 2021
• Primary Completion: April 8, 2021
• Study Completion: June 30, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

FR (1)