← Back to Search

Pressure Control Algorithm

CPAP v TPAP for Obstructive Sleep Apnea

N/A

Recruiting

Led By Abinash Joshi, MD

Research Sponsored by SleepRes Inc.

Eligibility Criteria Checklist

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

Must have

Age range between 18 and 70

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up all tests conducted in a 20 minute time frame on awake supine patients.

Awards & highlights

Study Summary

This trial is testing a new device called TheraPAP which is designed to treat obstructive sleep apnea. The device can deliver standard CPAP treatment or a new type of treatment called TPAP

Who is the study for?

This trial is for adults aged 18-70 with a BMI of at least 18 kg/m^2 and moderate to severe Obstructive Sleep Apnea (OSA), indicated by an AHI > 10. Participants must be new to CPAP treatment. Those with chronic lung diseases, other significant sleep disorders, recent serious illness or infection, or hypoglossal nerve stimulation implants cannot join.Check my eligibility

What is being tested?

The study compares two devices for OSA: the standard CPAP machine and a prototype called TPAP that adjusts pressure during breathing cycles. The goal is to see if TPAP offers better comfort than traditional CPAP when patients are awake and lying on their backs.See study design

What are the potential side effects?

While specific side effects are not listed for this trial, common issues with such devices may include discomfort from straps or masks, dry nose or throat, nasal congestion, headaches, and possible irritation from air pressure changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ all tests conducted in a 20 minute time frame on awake supine patients.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~all tests conducted in a 20 minute time frame on awake supine patients.

This trial's timeline: 3 weeks for screening, Varies for treatment, and all tests conducted in a 20 minute time frame on awake supine patients. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CPAP v TPAP Patient Preference via Visual Analog Scale

Secondary outcome measures

TPAP 1 v TPAP 2 Patient Preference via Visual Analog Scale

Trial Design

1Treatment groups

Experimental Treatment

Group I: CPAP v TPAPExperimental Treatment2 Interventions

Participants will compare CPAP to 2 different levels of TPAP, then will compare 2 levels of TPAP against each other by breathing on each pair of therapies for a minute or so, then deciding which is more comfortable or if they are equivalent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CPAP

2013

Completed Phase 3

~5460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SleepRes Inc.Lead Sponsor

1 Previous Clinical Trials

150 Total Patients Enrolled

Abinash Joshi, MDPrincipal InvestigatorUniversity of Louisville

1 Previous Clinical Trials

150 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for patients to participate in this ongoing research study?

"The clinical trial outlined on clinicaltrials.gov is currently not open for patient recruitment. The study was first listed on 2/5/2024 and last updated on 2/9/2024. It's worth noting that while this specific trial is inactive, there are a total of 274 other ongoing studies actively seeking participants."

Answered by AI

Which individuals are considered the most suitable candidates for participation in this research endeavor?

"To be eligible for participation, individuals must have a diagnosis of obstructive sleep apnea and fall within the age bracket of 18 to 70 years. The trial aims to enroll a total of 80 patients."

Answered by AI

Do participants above the age of 75 meet the criteria for enrollment in this research project?

"Individuals aged between 18 and 70 are sought after for this clinical research project. Notably, there are separate studies available for those younger than 18 or older than 65."

Answered by AI