Assessment of Tolerance to the Treatment of Obstructive Sleep Apnea by Shear Wave Inducer Collar (ET-SAOS-OC)
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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. 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.
    


Intervention name(s): shearing wave collar
Intervention type(s): Device
Intervention description(s): Collar inducing shearing wave to treat obstructive sleep disorders
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obstructive sleep disorders; polysomnography; collar; shear waves