Apnea Hypopnea Index Severity Versus Head Position During Sleep
Condition: Sleep Disordered Breathing; Sleep Hypopnea; Sleep Apnea; Sleep Apnea, Obstructive; Snoring
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring
Study type: Interventional

Summary: 
      This study evaluates the correlation of the position of the head during sleep, independent of
      the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
    

Detailed description: 
      Obstructive Sleep Apnea (OSA) is a common diagnosis in the general population, with a
      prevalence in the United States of 3-7% in men and 2-5% in women. It is defined as a
      sleep-related breathing disorder that results in decreased or complete cessation of airflow
      while the patient has ongoing breathing effort.

      It is well documented that trunk position significantly affects the severity of OSA. In fact,
      50-75% of individuals with a diagnosis of OSA show supine predominance or worsened
      apnea-hypopnea index (AHI) when sleeping in the supine position. Positional Obstructive Sleep
      Apnea (POSA) is defined as an AHI ≥5 with >50% AHI reduction between the supine and
      non-supine positions and AHI. Studies show 49.5% of individuals with mild OSA (AHI 5-15),
      19.4% with moderate OSA (AHI 15-30) and 6.5% in severe OSA (AHI > 30) had POSA. Due to this
      high prevalence of POSA, especially in the mild and moderate OSA populations, positional
      therapies have been developed and researched.

      In this clinical trial, if only the head position is considered, all subjects are positional
      sensitive and OSA severity can be calculated and consistently minimized by limiting the
      allowable range of head roll angle during sleep. Ten subjects underwent a standard
      polysomnography with an additional head angle sensor and coached to fall asleep in various
      head positions. Torso position was changed between supine and non-supine for a given head
      roll angle epoch to show the OSA severity change with torso position. Each sleep epoch of
      unique head pitch and roll angle was scored individually for AHI and Oxygen Saturation (SPO2)
      de-saturation.

      Investigators hypothesize that specific head roll angles independent of torso position will
      significantly reduce AHI and SpO2 desaturation severity in patients. The primary aim is to
      determine the head roll angles that significantly improve POSA independent of torso position.
      By doing this, Investigators believe to identify a "safe zone" of head roll angles that
      improve POSA and that can be used to support the development of head positional therapy for
      POSA patients.
    

Intervention name(s): Dual-axis inclinometer attached to the subject's forehead with tape
Intervention type(s): Device
Intervention description(s): This is the first clinical trial in the industry to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity. The apnea equation is based on the gravitational crush forces of the mass of the tongue and nearby tissue on the upper air way and is valid for most OSA sufferers.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science