TheraPAP vs APAP for Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new sleep device called TheraPAP, designed to treat obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep. Researchers aim to determine if TheraPAP is more comfortable and improves usage compared to the standard APAP device, a type of positive airway pressure device. Participants will use each device for four weeks at home, and researchers will collect data on their breathing and sleep quality. Suitable candidates have OSA with moderate to severe symptoms but no other sleep disorders or serious illnesses. As an unphased trial, this study allows participants to contribute to innovative research that could enhance comfort and effectiveness in sleep apnea treatment.
Will I have to stop taking my current medications?
Yes, if you are taking medications that affect sleep, sleepiness, or alertness, you will need to stop them to participate in this trial.
What prior data suggests that this device is safe for treating obstructive sleep apnea?
Research has shown that TheraPAP, a new device tested for obstructive sleep apnea (OSA), has promising safety results from earlier studies. The device meets key safety standards for electricity and isolation, ensuring safe use. Studies also indicate that TheraPAP remains comfortable without sacrificing effectiveness in treating OSA. This comfort is crucial, as it encourages adherence to therapy. Although TheraPAP is still under testing, these findings suggest it is well-tolerated by users.12345
Why are researchers excited about this trial?
Unlike the standard of care for obstructive sleep apnea, which typically involves automatic positive airway pressure (APAP) devices, TheraPAP offers a new approach under evaluation. Researchers are excited about TheraPAP because it might provide enhanced comfort and efficacy by optimizing pressure settings tailored to individual needs, potentially reducing air leaks and improving adherence. This innovation could lead to better sleep quality and outcomes for patients who struggle with traditional APAP devices.
What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?
This trial will compare TheraPAP with APAP for treating obstructive sleep apnea (OSA). Research has shown that TheraPAP, a new device for OSA, can increase patient comfort while maintaining effectiveness. In earlier studies, adding a special component to the CPAP machine made breathing easier, enhancing patient comfort without compromising treatment effectiveness. Another study found that TheraPAP can reduce sleepiness, improve quality of life, and enhance breathing over time. Users of similar devices have reported feeling less sleepy during the day and experiencing a better quality of life. These findings suggest that TheraPAP could be a promising option for managing OSA.26789
Who Is on the Research Team?
William H Noah, MD
Principal Investigator
SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC
Are You a Good Fit for This Trial?
This trial is for individuals with obstructive sleep apnea (OSA). Participants will use a special CPAP device that has two settings: TheraPAP and standard APAP. They must be willing to try both methods, each for six weeks, in a random order to compare which one they stick with better.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Arm 1
Participants use either KPAP or APAP device at home for 4 weeks
Washout
Participants undergo a 1-week washout period with no therapy
Treatment Arm 2
Participants switch to the other device (KPAP or APAP) for another 4 weeks
Follow-up
Participants are monitored for adherence and side effects after treatment
What Are the Treatments Tested in This Trial?
Interventions
- APAP
- TheraPAP
Trial Overview
The study tests the adherence of patients with OSA to two different pressure settings on a CPAP device: TheraPAP and standard APAP. It's designed as a crossover study where participants switch between therapies after six weeks to see which one they prefer using.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration.
Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SleepRes Inc.
Lead Sponsor
Citations
Comparative outcomes in obstructive sleep apnea therapy
The results of this large retrospective study suggest an at least comparable effectiveness of CPAP and multilevel surgery for OSA [16]. With 69 percent of CPAP ...
NCT06238362 | TheraPAP Equivalence Crossover Study
The device is generally considered efficacious with an apnea-hypopnea index in REM < 5 events/h, however it has to be noted that obstructive sleep apnea during ...
Comparing Treatment Effectiveness and Patient-Reported ...
Improves symptoms of OSA, showing significant improvements in sleepiness, quality of life, and respiratory outcomes after at least 48 months of treatment., ...
Positive airway pressure therapy adherence and outcomes in ...
In patients with OSA, PAP therapy has been shown to significantly reduce daytime sleepiness and hypertension; improve quality of life measures; and decrease ...
Treatments for obstructive sleep apnea: CPAP and beyond
Compared with scores in a control group, positional therapy improved the Epworth Sleepiness Scale score by 1.58 points (a difference that is not ...
Study Details | NCT06264128 | TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) ... CPAP is a standard formal at home therapy for obstructive sleep apnea ...
Treatment of Adult Obstructive Sleep Apnea With Positive ...
The data demonstrated that PAP compared to no treatment results in a clinically significant reduction in disease severity, sleepiness, blood pressure, and motor ...
TPAP for Comfort in OSA | Clinical Research Trial Listing
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of ...
Positive Airway Pressure Therapy for Sleep Apnea
What prior data suggests that Positive Airway Pressure therapy is safe for sleep apnea patients? Research shows that Continuous Positive Airway Pressure ...
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