Prevention of Airway Obstruction Events

  • STATUS
    Recruiting
  • days left to enroll
    13
  • participants needed
    25
  • sponsor
    NovaResp Technologies Inc
Updated on 26 April 2022
obstructive sleep apnea

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.

Description

Patients recruited for the study will undergo two different PAP therapy treatments during sleep: a control treatment and an intervention treatment. Both types of treatment will be delivered using a positive airway pressure (PAP) device with an Investigational Testing Authorization (ITA) from Health Canada (HC). This medical device consists of a commercially available PAP device which has been integrated with a feature to communicate with a computer hosting the predictive software via USB. Using signals received from the PAP device, the software can predict incoming apneas and direct the PAP machine to increase pressure for a short period of time; This study has been designed as a single-blind, randomised crossover study, in which recruited patients who suffer from Obstructive Sleep Apnea (OSA) will undergo at least two sleep studies. During a sleep study, the patient will spend a night of sleep at the sleep clinic (Sleep Disorders Clinic, QEII Abbie J. Lane Memorial Building) and receive one of two PAP therapy treatments; For the control treatment, the PAP device will deliver standard PAP therapy treatment to the patient; For the intervention treatment, the PAP device will deliver the standard PAP therapy treatment in addition to intervention when an apnea is predicted; All recruited participants will undergo at least two study nights and receive both treatments at least once; For all study night, standard Polysomnography (PSG) measurements will also be acquired (breathing rate, brain waves, movement, blood rate, oxygen levels, etc.); Participants will not be told what therapies are being used for each night, and the device used will be concealed from their view; After each night, participants will be asked to fill out a Satisfaction/Adherence questionnaire.

Details
Condition Sleep Apnea, Mixed Central and Obstructive
Treatment cMAP Flow V 2.0
Clinical Study IdentifierNCT04873024
SponsorNovaResp Technologies Inc
Last Modified on26 April 2022

Eligibility

Yes No Not Sure

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

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 safety of the participant
Subjects exhibiting any flu-like or any upper airway tract infection symptoms at the time of assessment
Pregnant (confirmed verbally)
Inability or unwillingness of individual to give written informed consent
Has received bariatric surgery
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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