Clinical trial NCT04086407: Apnea Hypopnea Index Severity Versus Head Position During Sleep
Official title: The Effect of Head Pitch and Roll Rotation Independent of Torso Rotation on the AHI in Positional Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Sleep Hypopnea
Sleep Apnea
Sleep Apnea, Obstructive
Snoring
Lead sponsor: Sleep Systems
Sponsor class: INDUSTRY
Collaborators: name: New England IRB
name: Mass Lung and Allergy, PC
First posted: 2019-09-11
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participant has provided written informed consent
* Participant is diagnosed with Positional Obstructive Sleep Apnea
* Participant age is between 21 and 60 years
* If currently on Positive Air Pressure (PAP) therapy, is able to produce compliance data within the last week before screening visit
* Is able to follow directions during the overnight sleep study
* If currently on PAP therapy participant self-report that excessive daytime sleepiness persists when PAP therapy is not in use
* Able to be of "PAP" therapy for 4 nights

Exclusion Criteria:

* Documented diagnosis of Insomnia
* Chronic ear infections
* Persistent neck "pains"
* Persistent chronic posture physical issues
* Previous C-Spine fusion
* History of Cardiac Arrythmia
* History of seizures
* Allergic to Standard Tape used in Sleep Centers
* Non-English speaking.
* Hospitalization within the previous 4 weeks
* Use of antibiotics or steroids within the previous 4 weeks
* Any major uncontrolled disease or condition, such as congestive heart failure, malignancy, end-stage heart disease, end-stage heart disease. Arterial Laterial Sclerosis (ALS), or sever stroke, or other condition as deemed appropriate by investigator as determined by review of medical history and/or participant reported medical history
* History of severe osteoporosis
* Excessive alcohol intake (\> 6oz hard liquor, 48 oz beer or 20 oz wine daily), or illicit drug use by review of medical history and/or participant reported medical history
* Daily use of prescribed narcotics (greater than 30 mg morphine equivalent)

Primary outcomes:
measure: Number of Participants With Apnea Hypopnea Index (AHI) Severity Improvement
timeFrame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
measure: Number of Participants With SpO2 Desaturation Severity Improvement
timeFrame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
measure: Number of Participants With Improvement Independent of Torso Using Forehead Mounted Pitch and Roll Angle Sensor
timeFrame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
measure: Torso Independent With SpO2 Improvement Using Forehead Mounted Pitch and Roll Angle Sensor
timeFrame: 8 hour polysomnography study with subjects being assessed at each head pitch and roll angle epoch
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Mass Lung and Allergy
state: Massachusetts
Study officials:
affiliation: Mass Lung and Allergy
name: Stacia Sailer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass Lung and Allergy
name: Payam Aghazzi, MD
role: PRINCIPAL_INVESTIGATOR
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