Drug Induce Sleep EndoscopyDISENCT05091164
Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
A study testing Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis in people with Drug Induce Sleep Endoscopy and Hypnosis, run by Elsan at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Induce Sleep Endoscopy, Hypnosis, Obstructive Sleep Apnea Syndrome
- What is being tested?
- Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug induce sleep endoscopy of upper aerodigestive tract under hypnosisProcedure or surgery
Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start8 Feb 2021
- Primary completion8 Apr 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Induce Sleep EndoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Polyclinique Poitiers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091164
- Sponsor's protocol ID
- 2020-A02419-30
- Acronym
- DISE
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Sleep Endoscopy Under Hypnosis in a Sleep Center
- ClinicalTrials.gov ID
- NCT05091164
- Acronym / sponsor ID
- DISE / 2020-A02419-30
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Polyclinique Poitiers
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate obstructive sleep apnea syndrome patient under hypnosis | Experimental | Procedure: Drug induce sleep endoscopy of upper aerodigestive tract under hypnosisPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug induce sleep endoscopy of upper aerodigestive tract under hypnosisDrug induce sleep endoscopy of upper aerodigestive tract under hypnosis. | Procedure or surgery | Moderate obstructive sleep apnea syndrome patient under hypnosis |
Primary outcome
proportion of patients for whom the DISE could be performed in good conditions of comfort
Time frame: 45 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug induce sleep endoscopy of upper aerodigestive tract under hypnosis in people with Drug Induce Sleep Endoscopy and Hypnosis, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients for whom the DISE could be performed in good conditions of comfort (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.