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

Elsan

Status: Completed

Conditions: Hypnosis; Drug Induce Sleep Endoscopy; Obstructive Sleep Apnea Syndrome

Treatments: Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05091164

2020-A02419-30

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Moderate obstructive sleep apnea syndrome patient under hypnosis

Experimental group

Description:

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.

Treatment:

Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis