Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center (DISE)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome; Hypnosis; Drug Induce Sleep Endoscopy
• Intervention / Treatment: Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Potiers, France
    • Centre du Sommeil de la Polyclinique de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Moderate obstructive sleep apnea syndrome patient under hypnosis; 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; Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.

What is the study measuring?

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 comfortPhysical comfort (5 items)Psychological comfort (5 items); Practitioner comforto 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

Collaborators and Investigators

• Sponsor: Elsan
• Collaborators: European Clinical Trial Experts Network; Polyclinique Poitiers

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Actual): April 8, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2020-A02419-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No