CompletedNot Applicable

Prevention of Airway Obstruction Events

Canada15 participantsStarted 2021-12-01

Plain-language summary

The standard for treatment for people suffering from obstructive sleep apnea (OSA) syndrome involves the use of Continuous, or Automatic Positive Airway Pressure (CPAP, APAP) machines, which work by delivering air via tubing and mask to a patient at pressures of up to 20cmH2O. This increased pressure is meant to stabilize the airway to reduce obstruction events. APAP machines are generally more effective and more comfortable for patients than CPAP machines because these devices automatically adjust pressure to treat an apnea. However, this treatment is reactive and often ineffective since the necessary pressure is applied seconds after breathing has already stopped; The results of a previous study performed showed strong indications for predicting an apnea before it occurs using measurements collected by existing sensors of the CPAP and APAP machines. If apnea events can be predicted before they occur, the air pressure required to treat them could be supplied ahead of time, preventing the apnea from occurring. The hypothesis to be tested is whether obstructive sleep apnea events can be prevented, by predicting their onset ahead of time and adjusting the airway pressure accordingly.

Who can participate

Age range

18 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: * No history of self-reported cardiovascular or neurological issues * Must be a current PAP machine user. * Must have used PAP machines for more than 4 months. * Must be at least 18 years old * Must be able to comply with all study requirements as outlined in the consent form * Must be able to understand English and be willing to provide written informed consent * For all nights of the study, participant must be willing to lend their personal PAP device for inspection. * Must be willing to have their CPAP SD memory card analyzed by OSCAR to determine their average OAI over the past 30 days of use. * For the low OAI group, participants must have an average OAI between 0.8 - 2.99 and AHI \< 5.0 in the past 30 days, which would result in at least one obstructive apnea every two hours each night. * For the high OAI group, participants must have an average OAI ≥ 3.0 and AHI ≥ 5.0 in the past 30 days, which would result in around 5 obstructive apneas every hour each night. Exclusion Criteria: * Subjects actively using bi-level PAP or require oxygen therapy * History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months * Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness) * Potential sleep apnea complications that in the opinion of the clinician may affect the health and…

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

Apnea-Hypopnea Index (AHI)

Timeframe: 2 nights (approx. 8hrs/night)

Obstructive Apnea Index

Timeframe: 2 nights (approx. 8hrs/night)

Respiratory Disturbance Index

Timeframe: 2 nights (approx. 8hrs/night)

Trial details

NCT IDNCT04873024

SponsorNovaResp Technologies Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-08-12

View on ClinicalTrials.gov More Sleep Apnea, Mixed Central and Obstructive trials

Plain-language summary

Who can participate

Age range

18 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.