CompletedNot Applicable

Apnea Hypopnea Index Severity Versus Head Position During Sleep

United States8 participantsStarted 2016-11-28

Plain-language 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.

Who can participate

Age range21 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 med…

What they're measuring

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

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

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

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

Trial details

NCT IDNCT04086407

SponsorSleep Systems

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-19

Results submitted2019-09-24

View on ClinicalTrials.gov More Sleep Disordered Breathing trials