Status:
COMPLETED
Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar (ET-SAOS-OC)
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Sleep Apnea
Eligibility:
All Genders
30-69 years
Phase:
NA
Brief 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 ob...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05236075
Start Date
July 18 2022
End Date
May 4 2023
Last Update
May 17 2023
Active Locations (1)
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1
Department of sleep and respiratory disorders, Hopital Nord Croix-Rousse - Hospices Civils de Lyon
Lyon, France, 69004