Status:
COMPLETED
Apnea Hypopnea Index Severity Versus Head Position During Sleep
Lead Sponsor:
Sleep Systems
Collaborating Sponsors:
New England IRB
Mass Lung and Allergy, PC
Conditions:
Sleep Disordered Breathing
Sleep Hypopnea
Eligibility:
All Genders
21-60 years
Phase:
NA
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 disor...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04086407
Start Date
November 28 2016
End Date
November 30 2017
Last Update
June 30 2020
Active Locations (1)
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1
Mass Lung and Allergy
Worcester, Massachusetts, United States, 01605