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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention-first | Experimental | Participants in this arm will receive the Intervention treatment on the first night, and the control treatment on the second night. |
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| Control-first | Experimental | Participants in this arm will receive the Control treatment on the first night, and the Intervention treatment on the second night. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cMAP Flow V 2.0 | Device | Breathing data collected by the device will be processed by a machine learning algorithm to predict obstructive apnea events. When obstructive apnea events are predicted, the algorithm triggers the CPAP device to respond to the apnea event ahead of its onset. For the control treatment, the device will operate as its conventional treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. AHI is measured as the average number of Apnea and Hypopnea occurrences in an hour during sleep (units: events/hour). | 2 nights (approx. 8hrs/night) |
| Obstructive Apnea Index | To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. OAI is measured as the average number of exclusively Obstructive Apnea occurrences in an hour during sleep (units: events/hour). | 2 nights (approx. 8hrs/night) |
| Respiratory Disturbance Index | To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. RDI is measured as the average number of Apneas, Hypopneas and RERAs (Respiratory Effort Related Arousal) occurrences in an hour during sleep. | 2 nights (approx. 8hrs/night) |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Desaturation Index (ODI) | The ODI metric is also obtained through Polysomnography (PSG) data. ODI is measured as the average number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline (units: events/hour). | 2 nights (approx. 8hrs/night) |
| Intervention treatment has an effect on patient adherence |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Debra Morrison, M.D. | Nova Scotia Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Clinic | Halifax | Nova Scotia | B3H 2E2 | Canada |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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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
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Participants will not be informed what treatment will be used during the studies. The device that will be delivering therapy to them will be concealed from view throughout the study.
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Another objective will be the comparison of patient satisfaction after each night of sleep, which will be scored and quantified by an adherence/satisfaction questionnaire to determine whether the use of our device had a positive, or neutral effect on their sleep. The questionnaire will be given to participants to fill out after treatment. Questionnaire responses will be scaled to an Adherence score using a 11-point Likert rating scale. Higher scores indicate higher participant's adherence/satisfaction to the treatment. |
| 2 nights (approx. 8hrs/night) |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012131 | Respiratory Insufficiency |