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

Trial Summary

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 data supports the effectiveness of Positive Airway Pressure Therapy for Sleep Apnea?

Research shows that Continuous Positive Airway Pressure (CPAP) is effective for treating obstructive sleep apnea by maintaining open airways during sleep. Automatic CPAP devices, which adjust pressure levels as needed, are also effective. Bilevel Positive Airway Pressure (BPAP) can be a good alternative for patients who struggle with regular CPAP. ^{1 2 3 4 5}

Is positive airway pressure therapy generally safe for humans?

Positive airway pressure therapy, including CPAP and BiPAP, is generally safe but can have side effects like mask leaks and, in rare cases, can cause central apneas (pauses in breathing) and hypoventilation (reduced breathing) during sleep. ^{2 3 6 7 8}

How does Positive Airway Pressure Therapy for Sleep Apnea differ from other treatments for this condition?

Positive Airway Pressure Therapy, including CPAP and APAP, is unique because it uses a machine to deliver a steady stream of air through a mask to keep the airways open during sleep, unlike other treatments that may involve surgery or oral appliances. This therapy is non-invasive and can be adjusted automatically to the patient's needs, making it a flexible option for managing sleep apnea. ^{9 10 11 12 13}

What is the purpose of this trial?

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. The main question(s) it aims to answer are: 1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients. 2. To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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 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 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]

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]

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]

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]

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]

References

1. Australia 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. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Auto bi-level pressure relief-PAP is as effective as CPAP in OSA patients--a pilot study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Bilevel positive airway pressure worsens central apneas during sleep. [2013]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

CPAP adherence of patients with obstructive sleep apnea. [2022]

6. Hungary pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Compliance with CPAP therapy in patients with the sleep apnoea/hypopnoea syndrome. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[Errors and risks in administration of nasal respiratory therapy of obstructive sleep apnea]. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Pelvic floor physical therapy in patients with chronic anal fissure: long-term follow-up of a randomized controlled trial. [2023]

10. Finland pubmed.ncbi.nlm.nih.gov

[Treatment of severe constipation]. [2017]

11. United States pubmed.ncbi.nlm.nih.gov

Mucosal advancement flap anoplasty for chronic anal fissure resistant to conservative therapy. [2021]

12. India pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

[Functional disorders of the rectum and pelvic floor. Ambulatory/conservative therapy]. [2008]