Clinical trial NCT04873024: Prevention of Airway Obstruction Events
Official title: Real-time Prediction and Prevention of Apnea Events on PAP Machines in an Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Mixed Central and Obstructive
Keywords: APAP
CPAP
Airway obstructions
Lead sponsor: NovaResp Technologies Inc
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 and receive two treatments.

The intervention arm will be stratified into two groups based on their Obstructive Apnea Index (OAI):

Group 1 (n=11): Low OAI, 0.8 \< OAI \< 2.99 and AHI \< 5.0 Group 2 (n=11): High OAI, OAI \> 3.0, and AHI \> 5.0
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 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

All participants currently screened, enrolled, and consented who have not yet had all overnight testing done, AND who have an OAI \< 3.0 and AHI \< 5.0, will be excluded from the study, as this group has been fully enrolled to date.

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: 2 nights (approx. 8hrs/night)
measure: Obstructive Apnea Index
timeFrame: 2 nights (approx. 8hrs/night)
measure: Respiratory Disturbance Index
timeFrame: 2 nights (approx. 8hrs/night)
Secondary outcomes:
measure: Oxygen Desaturation Index (ODI)
timeFrame: 2 nights (approx. 8hrs/night)
measure: Intervention treatment has an effect on patient adherence
timeFrame: 2 nights (approx. 8hrs/night)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Sleep Disorders Clinic
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health
name: Debra Morrison, M.D.
role: PRINCIPAL_INVESTIGATOR
References: