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Procedure

TPAP - Experimental Therapy 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during overnight procedure

Awards & highlights

Study Summary

This trial, TheraEquivalence, is a study that will compare the effectiveness and safety of using TheraPAP (TPAP) with CPAP alone for treating obstructive sleep apnea (

Who is the study for?

This trial is for people who have been diagnosed with obstructive sleep apnea (OSA) and have an Apnea-Hypopnea Index (AHI) greater than 10. Participants should have used CPAP for at least 5 hours a night in the past two months and must have a BMI over 18.Check my eligibility

What is being tested?

The study is testing TheraPAP (TPAP), comparing it to the standard CPAP treatment to see if it's just as effective and safe in treating OSA. It's a Phase 2 trial where participants will switch between TPAP and CPAP treatments.See study design

What are the potential side effects?

Potential side effects may include discomfort or irritation from wearing the devices, dry mouth or nose, headaches, bloating, sore eyes, and skin marks from the mask.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during overnight procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during overnight procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during overnight procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Apnea/Hypopnea Index

Secondary outcome measures

Body Position AHI

Sleep Stage Apnea/Hypopnea Index (AHI)

Unintentional Patient Circuit Leak

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TPAP - Experimental TherapyExperimental Treatment1 Intervention

Experimental therapy in which pressure is reduced during inspiration and the reduction is carried through part of expiration such that the pressure is increased near the end of expiration.

Group II: CPAP - Traditional OSA TherapyActive Control1 Intervention

Standard OSA therapy to which the TPAP therapy will be compared for efficacy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SleepRes Inc.Lead Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

Abinash Joshi, MDPrincipal InvestigatorSleepRes Inc.

1 Previous Clinical Trials

80 Total Patients Enrolled

Frequently Asked Questions

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

How large is the participant pool for this particular research endeavor?

"Affirmative. Information available on clinicaltrials.gov signifies that this investigation is presently in search of candidates. The study was first published on March 7, 2024 and last revised on March 14, 2024. Enrollment for the trial aims to recruit a total of 150 individuals from one designated site."

Answered by AI

Do I meet the necessary criteria to participate in this research endeavor?

"The trial aims to enroll 150 individuals aged between 18 and 70 who are presently grappling with obstructive sleep apnea. Participants must also fulfill the subsequent conditions: a previous polysomnography recording an Apnea-Hypopnea Index (AHI) exceeding 10, consistent usage of CPAP for an average of 5 hours per night over the two months leading up to commencement of the study, and a body mass index (BMI) surpassing 18 kg/m2."

Answered by AI

Is there an age limit for participants in this medical study, particularly regarding individuals above the age of 40?

"To be eligible for participation, individuals aged between 18 and 70 are sought after. Notably, there are separate studies available specifically designed for those under 18 years old (43 studies) as well as individuals over the age of 65 (226 studies)."

Answered by AI