Positive Airway Pressure Therapy for Sleep Apnea

Overseen By Megan Neil, BScN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NovaResp Technologies Inc

Disqualifiers: Cancer, Dementia, Cardiac, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines adherence to two sleep apnea treatments: proactive CPAP (Continuous Positive Airway Pressure) and conventional APAP (Automatic Positive Airway Pressure) therapy. It aims to determine which method patients use more consistently over three months and one year, and whether differences in health outcomes, such as sleep quality and comfort, exist. The trial targets individuals newly diagnosed with moderate to severe obstructive sleep apnea who have not previously used PAP machines. As an unphased trial, it provides patients the opportunity to contribute to valuable research that could enhance future treatment options for sleep apnea.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your medications might interact with the trial.

What prior data suggests that Positive Airway Pressure therapy is safe for sleep apnea patients?

Research shows that Continuous Positive Airway Pressure (CPAP) therapy is commonly used to treat obstructive sleep apnea (OSA). Studies indicate that most patients find CPAP comfortable. This treatment is already popular for OSA and other conditions, such as sudden heart-related lung issues, suggesting it is generally safe.

Proactive CPAP Therapy, a specific type of CPAP, is also considered safe and effective. Research found that most people using CPAP for sleep apnea had positive results without serious side effects.

Overall, both proactive and regular CPAP therapies appear to be safe options for treating sleep apnea, based on current research and their use in similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about proactive CPAP therapy for sleep apnea because it offers a smarter approach to managing the condition. Unlike conventional APAP therapy, which adjusts air pressure only when breathing irregularities occur, proactive CPAP therapy anticipates these issues, adjusting the pressure in advance to prevent them. This proactive method aims to improve sleep quality and comfort, potentially leading to better adherence and outcomes for patients. By predicting and preventing breathing disruptions before they happen, this therapy could provide a more restful night's sleep for those suffering from sleep apnea.

What evidence suggests that this trial's treatments could be effective for sleep apnea?

Research has shown that Positive Airway Pressure (PAP) therapy effectively treats Obstructive Sleep Apnea (OSA). Studies have found that PAP can significantly enhance the quality of life for individuals with moderate to severe sleep apnea. Immediate benefits include normal breathing for 60% of users and fewer awakenings during sleep. Using PAP for at least four hours a night is associated with a lower risk of death. In this trial, participants will be assigned to different treatment arms. One arm will receive Proactive CPAP therapy, which involves patient participation and monitoring to improve adherence and overall sleep quality. Another arm will receive Conventional APAP therapy, serving as the control group. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 who have just been diagnosed with moderate or severe Obstructive Sleep Apnea (OSA), meaning they have more than 15 breathing interruptions per hour of sleep. Participants should be able to follow the study's procedures and understand English. Those with uncontrolled, severe heart or brain conditions cannot join.

Inclusion Criteria

Must be able to follow the directions of the study doctor and research team

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 informed consent

Exclusion Criteria

Prior use of PAP machines

I use a bi-level PAP machine or need oxygen therapy.

I might have sleep apnea that could impact my health and safety.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either proactive CPAP therapy or conventional APAP therapy for sleep apnea

3 months

Regular contact with sleep technician

Follow-up

Participants are monitored for adherence and health outcomes, with data collected by PAP device and self-reported questionnaires

9 months

Extension

Participants who are acceptant to therapy may continue for an additional 9 months

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Conventional APAP Therapy
• Proactive CPAP Therapy

Trial Overview The study compares two treatments for OSA: Proactive CPAP Therapy and standard Automatic-PAP (APAP) Therapy. It looks at how well patients stick to these therapies over short-term (3 months) and long-term periods (12 months), as well as their health outcomes like airway blockage during sleep, nightly use, mask fit, and patient feedback.

How Is the Trial Designed?

Group I: Proactive CPAP Therapy (Intervention) Experimental Treatment 1 Intervention

Patients will undergo CPAP enabled with proactive therapy.

Group II: Conventional APAP Therapy (Control) Active Control 1 Intervention

Patients will undergo conventional APAP therapy.

Conventional APAP Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as CPAP/APAP for:

• Obstructive Sleep Apnea (OSA)

Approved in European Union as CPAP/APAP for:

• Obstructive Sleep Apnea (OSA)

Approved in Canada as CPAP/APAP for:

• Obstructive Sleep Apnea (OSA)

Who Is Running the Clinical Trial?

NovaResp Technologies Inc

Lead Sponsor

Trials

4

Recruited

280+

Published Research Related to This Trial

In a study of 35 patients with moderate to severe obstructive sleep apnea (OSA), both Continuous Positive Airway Pressure (CPAP) and Auto Bi-level Pressure Relief-Positive Airway Pressure (ABPR-PAP) significantly reduced the apnea-hypopnea index (AHI), indicating effective treatment.

After 3 months, ABPR-PAP showed a comparable reduction in AHI to CPAP, with no significant differences in compliance or adverse events, suggesting that ABPR-PAP could be a comfortable alternative for patients who struggle with traditional CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auto bi-level pressure relief-PAP is as effective as CPAP in OSA patients--a pilot study. Blau, A., Minx, M., Peter, JG., et al.[2021]

Pelvic floor physical therapy significantly improved muscle tone and reduced pain in patients with chronic anal fissure over a 1-year follow-up, with a notable decrease in resting electromyographic values and a reduction in pain ratings.

Only 15.5% of patients experienced a recurrence of fissures after treatment, indicating that pelvic floor therapy is an effective long-term management strategy for chronic anal fissure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy in patients with chronic anal fissure: long-term follow-up of a randomized controlled trial. van Reijn-Baggen, DA., Elzevier, HW., Putter, H., et al.[2023]

In a study involving 211 patients, Bilateral Internal Sphincterotomy (BIS) for treating Chronic Anal Fissure (CAF) significantly reduced recurrence rates (only 1 recurrence in the BIS group compared to 12 in the Unilateral Internal Sphincterotomy (UIS) group, p < 0.001).

BIS also resulted in less postoperative pain compared to UIS (p < 0.001), while maintaining continence levels, indicating it may be a safer and more effective option for CAF treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral versus bilateral lateral internal sphincterotomy: a randomized controlled trial for chronic fissure in ano. Pujahari, AK.[2010]

Functional disorders of the ano-rectum and pelvic floor can often be effectively treated in an office setting through conservative methods or outpatient surgery, emphasizing the importance of early diagnosis.

Key treatments include restoring normal anatomy through procedures like rubber-band ligation for prolapses and excision of fissures, along with therapies aimed at normalizing bowel habits and strengthening pelvic floor muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional disorders of the rectum and pelvic floor. Ambulatory/conservative therapy]. Bock, JU., Jongen, J.[2008]

In a study of 502 patients over one year, 1-2% experienced serious complications from CPAP and BIPAP treatments for sleep-related breathing disorders, including long central apneas and severe hypoxemia.

Mask leakages and central apneas were common issues that could lead to ineffective therapy, highlighting the need for initial treatment to be conducted in controlled sleep laboratory settings to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. Stammnitz, A., Becker, H., Schneider, H., et al.[2016]

In a study of 52 patients with obstructive sleep apnea (OSA) who struggled with CPAP therapy, bilevel positive airway pressure (BPAP) was found to significantly improve adherence, with patients using BPAP for an average of 7 hours per night compared to just 2.5 hours with CPAP.

BPAP also required lower pressure settings than CPAP and resulted in better symptom control, as indicated by a decrease in the Epworth Sleepiness Scale score, demonstrating its potential as a more tolerable alternative for patients who cannot adhere to CPAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BPAP is an effective second-line therapy for obese patients with OSA failing regular CPAP: A prospective observational cohort study. Ishak, A., Ramsay, M., Hart, N., et al.[2021]

In a study involving 36 outpatients with obstructive sleep apnea syndrome (OSAS), automatic CPAP machines using estimated reference pressures were found to be as effective as those using fixed pressures in alleviating sleep and breathing disorders.

The results suggest that automatic CPAP can be effectively administered without the need for a titration sleep study, allowing for easier adjustments based on individual characteristics, although one patient did experience treatment failure due to an underestimated pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of automatic continuous positive airway pressure therapy that uses an estimated required pressure in the treatment of the obstructive sleep apnea syndrome. Sériès, F., Marc, I.[2019]

In a study of 26 patients with chronic anal fissures who underwent sphincter-sparing transanal mucosal advancement flap anoplasty (MAAP), the procedure was well tolerated, with only one case of a perianal abscess requiring treatment.

At follow-up periods of 2, 12, and 24 months, all patients reported being free of pain, with no recurrence of fissures or worsening of incontinence, suggesting that MAAP is an effective treatment option for chronic anal fissures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mucosal advancement flap anoplasty for chronic anal fissure resistant to conservative therapy. Ouaïssi, M., Giger, U., Sielezneff, I., et al.[2021]

Conventional treatments for constipation, like fiber supplements and laxatives, often fail for patients with severe cases, highlighting the need for alternative therapies.

Advanced options such as biofeedback therapy, botulin injections, sacral nerve stimulation, and surgical interventions (like bowel resection) provide effective solutions for intractable constipation and specific conditions like functional obstructed defecation syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of severe constipation]. Luukkonen, P., Hillilä, M.[2017]

Continuous positive airway pressure (CPAP) therapy is an effective treatment for obstructive sleep apnea, which can lead to reduced sympathetic nervous system activity and lower blood pressure.

CPAP therapy also improves inflammatory and metabolic parameters, contributing to a decreased risk of cardiovascular issues in patients with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Beneficial effect of continuous positive airway pressure therapy in obstructive sleep apnea syndrome]. Magyar, MT.[2015]

In a study of 648 patients with obstructive sleep apnea, only 38.3% attended follow-ups, revealing that while subjective adherence to CPAP/BPAP was high at 85.1%, objective adherence was lower at 64.5%.

Factors influencing adherence included significant improvements in daytime sleepiness and overall sleep satisfaction, with younger patients showing better adherence to CPAP/BPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CPAP adherence of patients with obstructive sleep apnea. Salepci, B., Caglayan, B., Kiral, N., et al.[2022]

In a study of 54 patients with sleep apnoea/hypopnoea syndrome, the average nightly usage of CPAP therapy was only 4.7 hours, which is less than the recommended duration for effective treatment.

There was no correlation between the severity of sleep apnoea and the amount of CPAP used, and patients who experienced side effects from the therapy tended to use it significantly less, highlighting the importance of monitoring and addressing side effects to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. Engleman, HM., Martin, SE., Douglas, NJ.[2019]

In a study of 95 patients using bilevel positive airway pressure (BLPAP) therapy, it was found that BLPAP significantly worsened central sleep apnea events, including Cheyne-Stokes respiration (CSR) and non-CSR central apneas, compared to continuous positive airway pressure (CPAP).

During REM sleep, while central apneas improved, BLPAP was associated with worsening hypopneas and obstructive apneas, highlighting the need to consider potential adverse effects of BLPAP on sleep quality and cardiac function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilevel positive airway pressure worsens central apneas during sleep. Johnson, KG., Johnson, DC.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5436801/

IMPACT OF CONTINOUS POSITIVE AIRWAY PRESSURE ... We found that long-term improvement in quality of life occurs with the use of CPAP in persons with severe and possibly moderate sleep apnea.

2. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29993

Immediate Effect of Continuous Positive Airway Pressure ... It showed immediate benefits in most cases, including normalization of respiratory measures in 60% of patients, lower arousal index, and ...

3. pcori.org pcori.org/research-results/2016/comparing-two-methods-improve-cpap-use-among-patients-copd-and-obstructive-sleep-apnea-o2verlap-study

Comparing Two Methods to Improve CPAP Use among ... The research team wanted to compare how well the two types of care improved patients' use of CPAP and their sleep outcomes.

4. publications.ersnet.org publications.ersnet.org/content/erjor/10/1/00424-2023

Positive airway pressure telehealth models and long-term ... This study investigated long-term PAP therapy termination in patients with sleep apnoea managed with standard care, telemonitoring-guided proactive care.

5. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12304072/

Auto-adjusting positive airway pressure: the fine line between ... This review aims to bridge the gap between the clinical and engineering perspectives of APAP, providing an up-to-date overview of current ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06319482

The Adherence of Proactive Sleep Apnea Therapy The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482178/

Continuous Positive Airway Pressure - StatPearls - NCBI - NIH CPAP is widely used in the management of obstructive sleep apnea, acute cardiogenic pulmonary edema, and selected cases of mild acute respiratory distress ...