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

Primary Purpose

Drug Induce Sleep Endoscopy, Hypnosis, Obstructive Sleep Apnea Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Drug Induce Sleep Endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre du Sommeil de la Polyclinique de Poitiers

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Moderate obstructive sleep apnea syndrome patient under hypnosis

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 15, 2021
Last Updated
October 21, 2021
Sponsor
Elsan
Collaborators
European Clinical Trial Experts Network, Polyclinique Poitiers
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1. Study Identification

Unique Protocol Identification Number
NCT05091164
Brief Title
Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
Acronym
DISE
Official Title
Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
April 8, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan
Collaborators
European Clinical Trial Experts Network, Polyclinique Poitiers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Induce Sleep Endoscopy, Hypnosis, Obstructive Sleep Apnea Syndrome

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate obstructive sleep apnea syndrome patient under hypnosis
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis
Intervention Description
Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.
Primary Outcome Measure Information:
Title
proportion of patients for whom the DISE could be performed in good conditions of comfort
Description
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.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Centre du Sommeil de la Polyclinique de Poitiers
City
Potiers
Country
France

12. IPD Sharing Statement

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Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center

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