TheraPAP Equivalence Crossover Study

NCT06238362 | Completed Results FDA Device

• 1 other identifier: TheraEquivalence
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea/Hypopnea Index

  Gold standard measure of CPAP therapy efficacy. Scored as number of respiratory events per hour of sleep. The device is considered efficacious with an apnea-hypopnea index \< 5 events/h.

  During overnight procedure, on average 3.5 hours for each intervention

Secondary Outcomes (5)

• REM Apnea/Hypopnea Index (AHI)

  During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention

• Supine AHI

  During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention

• Unintentional Patient Circuit Leak

  During overnight procedure

• NREM Apnea/Hypopnea Index (AHI)

  During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention

• Lateral AHI

  During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention

Study Arms (2)

TPAP - Experimental Therapy

EXPERIMENTAL

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.

Other: TPAP

CPAP - Traditional OSA Therapy

ACTIVE COMPARATOR

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

Device: CPAP

Interventions

TPAP OTHER

Algorithm for modification of CPAP therapy where pressure is reduced during the inspiratory phase though much of the expiratory phase, then is returned to full pressure near the end of the expiratory phase. Note that the same device that delivers CPAP can also deliver TPAP

Also known as: TheraPAP

TPAP - Experimental Therapy

CPAP DEVICE

Gold standard for treating sleep apnea.

CPAP - Traditional OSA Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI \> 10 on a previous PSG.
• CPAP adherence for an average of 5 h/night in the 2 months before the study
• BMI above 18 kg/m2, inclusive.

You may not qualify if:

• Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI \> 5 events/h).
• Current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (\>140/90mmHg).
• Current clinically significant neurological disorder, including epilepsy/convulsions.
• Other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.
• Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) or International Classification of Disease tenth edition criteria.
• Attempted suicide within 1 year prior to screening, or current suicidal ideation.
• History of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
• A serious illness or infection in the past 30 days as determined by investigator.
• Clinically significant cognitive dysfunction as determined by investigator.
• Chronic oxygen therapy.
• Patients with hypoglossal nerve stimulation implant.
• Any non-previously mentioned vulnerable population.
• Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation.

Sponsors & Collaborators

• SleepRes Inc.: lead

Study Sites (1)

SleepCenters of Middle Tennessee

Clarksville, Tennessee, 37043, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Bernard Hete
• Organization: SleepRes

bhete@sleepres.com

+1 615-921-2406

Study Officials

• Abinash Joshi, MD

  SleepRes Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be asleep during both therapies.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 2, 2024
• Study Start: March 7, 2024
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)