Sleep ApneaET-SAOS-OCNCT05236075
Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar (ET-SAOS-OC)
A study testing shearing wave collar in people with Sleep Apnea, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- shearing wave collar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2022to 4 May 2023
- 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 30 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- aged 30 to 69 in order to avoid tissue changes in the older age groups of the adult population
- patients with polysomnography diagnosic of obstructive sleep disorders moderate to severe
- referred to the Sleep Center of the Croix Rousse Hospital for sleep disorders and suspected of having a sleep apnea syndrome when first making contact in consultation or by phone call.
- All patients accepting the additional 24 hours instead of the usual 24 hours, ECG, neck vessel Doppler and trial shear wave therapy. This second night will be scheduled at the end of the first night.
- Patients agreeing to spend this second night in a period of less than 15 days between the first night and the second night
Show all 10Show fewer
- Patient without fever >38°C
- having communicated their signed consent
- Affiliated with a social security scheme
- Having a negative PCR covid test in the last 48 hours prior to hospitalization, if used during the protocol.
Who cannot join
- Patient with a cardiac pace maker
- Patient with a tracheostomy
- Patient with cancerous disease during treatment
- Persons referred to in articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, cannot be included in clinical trials
- Patient unable to remove their dentures if concerned
- Patients with vascular plaques seen on cervical Doppler
Show all 11Show fewer
- Patient having presented a pathology in the previous months which contraindicates the continuation of the study at the discretion of one of the medical investigators (new cardiac pathology of less than 3 months, or of 6 months and not stabilized, vascular accident cerebral or transient ischemic attack of less than 3 months, other pathologies of less than 3 months at the discretion of the investigator).
- Patients with any known cutaneous or deep cervical abnormality (dermatosis, glottic abnormality, Zencker's diverticulum, Basedow, toxic thyroid nodule(s), parathyroid adenoma or hyperplasia, wound, recent scar, burn, etc.)
- Patients with an implanted electronic device, medical or not; other than implanted automatic pacemakers or pacemakers and defibrillators (cochlear implant, brain implants, RFID chip).
- Patients suffering from Central nervous sytem disorder such as epilepsy, Parkinson disease.
- Patients with a cervical malformation or a particular cervical morphology (very wide neck outside collar size range, goiter, etc.) incompatible with the characteristics of the collar.
Trial locations and contacts
1 site in 1 country.
France1 site
Department of sleep and respiratory disorders, Hopital Nord Croix-Rousse - Hospices Civils de Lyon
Lyon, 69004
About this study
Official title: Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined.
OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents.
Read more
The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor.
Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles.
Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down.
The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure.
The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies.
The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.
- Conditions
- Sleep Apnea
- Being tested
- shearing wave collar
- Keywords
- obstructive sleep disorders, polysomnography, collar, shear waves
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shearing wave collarDevice
Collar inducing shearing wave to treat obstructive sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| patients with polysomnography diagnostic of obstructive sleep disorders moderate to severe | Experimental | Not described Receives: Device: shearing wave collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of wearing the shear wave collar
The feasibility of wearing the shear wave collar will be determined by the percentage of patients who have worn the collar at least 60% of their night AND who agree to wear this shear wave diffuser collar again if treatment is necessary.
The duration collar wearing will be the delay in minutes between the putting on of the collar by a nurse and the removal of the collar by the patient or a nurse. The night duration will be the total duration of sleep in minutes determined by the polysomnography measures. The exact times (accuracy in second) of putting on and taking off the collar will be collected via the collar sensors specifically provided for this purpose. After each session, collar data are extracted by the BREAS technician and entered into the patient medical file and the eCRF.
Measured: Day after the polysomnographic night (Day1 or Day15)
Secondary outcomes (17)
Sleep quality
quality of sleep according to the patient will be assessed using the question: "I am satisfied with my night" with a 5-level Likert scale: very satisfied, satisfied, no opinion, moderately satisfied, not satisfied
Measured: Day after the polysomnographic night (Day1 or Day15)
confort during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "How do you judge the collar confort" with a 5-level Likert scale: very satisfied, satisfied, no opinion, moderately satisfied, not satisfied
Measured: Day after the polysomnographic night (Day1 or Day15)
vibration occurring during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "How do you judge the collar vibration" with a 5-level Likert scale: very satisfied, satisfied, no opinion, moderately satisfied, not satisfied
Measured: Day after the polysomnographic night (Day1 or Day15)
Noise occurring during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "How do you judge the collar noise" with a 5-level Likert scale: very satisfied, satisfied, no opinion, moderately satisfied, not satisfied
Measured: Day after the polysomnographic night (Day1 or Day15)
inconveniences due to the collar lock
inconveniences according to the patient will be assessed using the question: "How do you judge the collar lock" with a 5-level Likert scale: very satisfied, satisfied, no opinion, moderately satisfied, not satisfied
Measured: Day after the polysomnographic night (Day1 or Day15)
redness occurring during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "Do you have redness" with a 4-level Likert scale: None, Light, moderate, intense
Measured: Day after the polysomnographic night (Day1 or Day15)
Burnt occurring during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "Do you have Burnt " with a 4-level Likert scale: None, Light, moderate, intense
Measured: Day after the polysomnographic night (Day1 or Day15)
blisters occurring during the night wearing the collar
inconveniences according to the patient will be assessed using the question: "Do you have blisters " with a 4-level Likert scale: None, Light, moderate, intense
Measured: Day after the polysomnographic night (Day1 or Day15)
Pain occurring during the night wearing the collar
Pain according to the patient will be assessed using the question using anumeric scale from 0 to 10, 0 being the absence of pain and 10 the worst pain experienced
Measured: Day after the polysomnographic night (Day1 or Day15)
Hypertension safety
Hypertension evolution between before and 1 day after the polysomnographic night will be measures in mmHg
Measured: Day after the polysomnographic night (Day1 or Day15)
cardiac frequency safety
cardiac frequency evolution between before and Day after the polysomnographic night will be measures in mean frequency
Measured: Day after the polysomnographic night (Day1 or Day15)
adverse event post evaluation
Adverse event related to the night wearing the collar declared in the 7 days following the second polysomnographic night.
Measured: 7 Days after the second polysomnographic night (Day8 or Day22)
Sleep Apnea severity during the night wearing the collar
Sleep Apnea severity will be evaluated with the apnea-hypopnea index
Measured: Day after the polysomnographic night (Day1 or Day15)
Sleep fragmentation during the night wearing the collar
Sleep fragmentation level will be evaluated with the number of micro wake-up
Measured: Day after the polysomnographic night (Day1 or Day15)
duration of sleep stage during the night wearing the collar
duration of sleep stage in minutes
Measured: Day after the polysomnographic night (Day1 or Day15)
sleep efficacy during the night wearing the collar
sleep efficacy will be measured using the index time of real sleep in minutes divided by the time spent in bed in minutes
Measured: Day after the polysomnographic night (Day1 or Day15)
Night oxygen saturation during the night wearing the collar
Night oxygen saturation will be measured using the SaO2 mean
Measured: Day after the polysomnographic night (Day1 or Day15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start18 Jul 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236075
- Sponsor's protocol ID
- 69HCL21_1339
- Other IDs
- 2021-A03183-38
- Acronym
- ET-SAOS-OC
- Status last verified
- May 2023
- First submitted
- 17 Jan 2022
- Last updated
- 17 May 2023
- 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 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar
- ClinicalTrials.gov ID
- NCT05236075
- Acronym / sponsor ID
- ET-SAOS-OC / 69HCL21_1339
- Conditions
- Sleep Apnea
- Keywords
- obstructive sleep disorders, polysomnography, collar, shear waves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 11 Feb 2022 (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.
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined.
OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents.
The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor.
Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles.
Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down.
The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure.
The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies.
The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with polysomnography diagnostic of obstructive sleep disorders moderate to severe | Experimental | Device: shearing wave collar |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women
- aged 30 to 69 in order to avoid tissue changes in the older age groups of the adult population
- patients with polysomnography diagnosic of obstructive sleep disorders moderate to severe
- referred to the Sleep Center of the Croix Rousse Hospital for sleep disorders and suspected of having a sleep apnea syndrome when first making contact in consultation or by phone call.
- All patients accepting the additional 24 hours instead of the usual 24 hours, ECG, neck vessel Doppler and trial shear wave therapy. This second night will be scheduled at the end of the first night.
Key exclusion criteria (11 listed)
- Patient with a cardiac pace maker
- Patient with a tracheostomy
- Patient with cancerous disease during treatment
- Persons referred to in articles L1121-5 to L1121-8 of the CSP (pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, cannot be included in clinical trials
- Patient unable to remove their dentures if concerned
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 |
|---|---|---|
| shearing wave collarCollar inducing shearing wave to treat obstructive sleep disorders | Device | patients with polysomnography diagnostic of obstructive sleep disorders moderate to severe |
Primary outcome
feasibility of wearing the shear wave collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
The feasibility of wearing the shear wave collar will be determined by the percentage of patients who have worn the collar at least 60% of their night AND who agree to wear this shear wave diffuser collar again if treatment is necessary. The duration collar wearing will be the delay in minutes between the putting on of the collar by a nurse and the removal of the collar by the patient or a nurse. The night duration will be the total duration of sleep in minutes determined by the polysomnography measures. The exact times (accuracy in second) of putting on and taking off the collar will be collected via the collar sensors specifically provided for this purpose. After each session, collar data are extracted by the BREAS technician and entered into the patient medical file and the eCRF.
17 secondary outcomes
Sleep quality
Time frame: Day after the polysomnographic night (Day1 or Day15)
confort during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
vibration occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Noise occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
inconveniences due to the collar lock
Time frame: Day after the polysomnographic night (Day1 or Day15)
redness occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Burnt occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
blisters occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Pain occurring during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Hypertension safety
Time frame: Day after the polysomnographic night (Day1 or Day15)
cardiac frequency safety
Time frame: Day after the polysomnographic night (Day1 or Day15)
adverse event post evaluation
Time frame: 7 Days after the second polysomnographic night (Day8 or Day22)
Sleep Apnea severity during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Sleep fragmentation during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
duration of sleep stage during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
sleep efficacy during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
Night oxygen saturation during the night wearing the collar
Time frame: Day after the polysomnographic night (Day1 or Day15)
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 17 May 2023.
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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 shearing wave collar in people with Sleep Apnea, run by Hospices Civils de Lyon 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 10 inclusion and 11 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 17 May 2023. 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?
feasibility of wearing the shear wave collar (time frame: Day after the polysomnographic night (Day1 or Day15)). 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 17 May 2023.