Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

Obstructive Sleep Apnea Syndrome Clinical Trial

— DISE  

Official title:

Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05091164
• Other study ID #: 2020-A02419-30
• Status: Completed
• Phase: N/A
• Start date: February 8, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Elsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 30, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypnosis
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Centre du Sommeil de la Polyclinique de Poitiers	Potiers

Sponsors (3)

Lead Sponsor	Collaborator
Elsan	European Clinical Trial Experts Network, Polyclinique Poitiers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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