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 range

21 Years – 60 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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