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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
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.
Mass Lung and Allergy
Worcester, Massachusetts, United States
Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon)
Time frame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Number of Participants With SpO2 Desaturation Severity Improvement
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation for the total time duration spent sleeping in each head position. The key measurement is the subjects' relative improvement in SpO2 de-saturation with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon)
Time frame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of apnea hypopnea index (AHI) as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in AHI with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon) independent of torso position
Time frame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor
Investigators will perform a standard polysomnography with the addition of a precision forehead mounted angular sensor and monitor the severity of SpO2 desaturation as subjects sleep with the torso in the supine position while the head is ≤ 20⁰ and with the torso in the non-supine position while the head is above 45 degrees. The key measurement is the subjects' relative improvement in SpO2 desaturation with the head supine (45⁰ to 135⁰) as compared to non-supine (\<20⁰above the horizon) independent of torso position
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Time frame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch