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Auto-titrated PAP

TheraPAP vs APAP for Obstructive Sleep Apnea

N/A

Waitlist Available

Research Sponsored by SleepRes Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Female of child-bearing potential that is pregnant or intends to become pregnant

Chronic oxygen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up filled out twice, once after completion of each 6-week arm (after week 6 and after week 13)

Summary

"This trial will compare the adherence to therapy between a new treatment approach called TheraPAP and the standard treatment APAP for obstructive sleep apnea. TheraPAP is a pressure control algorithm

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, typical CPAP-related side effects may include discomfort or irritation at the mask site, dry nose or throat, runny nose, sneezing, congestion, and possible air leakage from the mask.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant or planning to become pregnant.

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I use oxygen therapy regularly.

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I am taking medication that could affect my sleep or alertness.

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I have a diagnosed sleep disorder.

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I have received treatment for sleep apnea before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ filled out twice, once after completion of each 6-week arm (after week 6 and after week 13)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~filled out twice, once after completion of each 6-week arm (after week 6 and after week 13)

This trial's timeline: 3 weeks for screening, Varies for treatment, and filled out twice, once after completion of each 6-week arm (after week 6 and after week 13) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Usage

Secondary study objectives

AHI

ESS Questionnaire

Excess Leak or Leak

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 6-weeks breathing on TheraPAPExperimental Treatment1 Intervention

Patients will breathe on TheraPAP for 6 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration.

Group II: 6-weeks breathing on APAPPlacebo Group1 Intervention

Patients will breathe on APAP for 6 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration.

0 / 5Eligibility criteria met