Prevention of Airway Obstruction Events

NCT04873024 | Completed

• 1 other identifier: Interventional-study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Mixed Central and Obstructive

Keywords

APAP; CPAP; Airway obstructions

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (2)

• Oxygen Desaturation Index (ODI)

  2 nights (approx. 8hrs/night)

• Intervention treatment has an effect on patient adherence

  2 nights (approx. 8hrs/night)

Study Arms (2)

Intervention-first

EXPERIMENTAL

Participants in this arm will receive the Intervention treatment on the first night, and the control treatment on the second night.

Device: cMAP Flow V 2.0

Control-first

EXPERIMENTAL

Participants in this arm will receive the Control treatment on the first night, and the Intervention treatment on the second night.

Device: cMAP Flow V 2.0

Interventions

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.

Also known as: Proactive airway management

Control-first; Intervention-first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaResp Technologies Inc: lead

Study Sites (1)

Sleep Disorders Clinic

Halifax, Nova Scotia, B3H 2E2, Canada

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Airway Obstruction

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Insufficiency

Study Officials

• Debra Morrison, M.D.

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: May 5, 2021
• Study Start: December 1, 2021
• Primary Completion: August 12, 2022
• Study Completion: August 12, 2022
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)