TheraPAP Equivalence Crossover Study

NCT ID: NCT06238362

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2024-07-08

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.

Detailed Description

The TheraEquivalence Study is a randomized, controlled, crossover study in participants with OSA. A split-night polysomnogram (PSG) will be conducted on CPAP and TPAP (3.5 h each treatment arm) in previously diagnosed OSA patients, to test the effectiveness of TPAP vs. CPAP. The sequence of periods for each participant are assigned in random order. Therapeutic CPAP level will be defined based on each individual's pressure levels from their currently used APAP device deemed to eliminate breathing obstructions for at least 90/95% of the sleep period (P90/P95) + 1 cmH2O (cm of water pressure). P90/P95 will be defined based on the previous 2 months of adherent Auto-adjusted Positive Airway Pressure (APAP) usage (defined as averaging > 5 hrs/night). On TPAP Tthe pressure drop during inspiration is generally done in two steps and varies, as outlined in table 1, based on the set pressure level, with larger drops occurring when the set pressure is higher. However, the pressure never goes below 5 cm H20. This lower pressure is returned to the set pressure level about halfway through expiration. These pressure drops are designed to make TPAP considerably more comfortable than CPAP.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TPAP - Experimental Therapy

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 Type: EXPERIMENTAL

TPAP

Intervention Type: 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

CPAP - Traditional OSA Therapy

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

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

Gold standard for treating sleep apnea.

Interventions

TPAP

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

Intervention Type: OTHER

CPAP

Gold standard for treating sleep apnea.

Intervention Type: DEVICE

Other Intervention Names

TheraPAP

Eligibility Criteria

Inclusion Criteria

1. AHI > 10 on a previous PSG.

2. CPAP adherence for an average of 5 h/night in the 2 months before the study

3. BMI above 18 kg/m2, inclusive.

Exclusion Criteria

1. 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).

2. Current clinically unstable cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (>140/90mmHg).

3. Current clinically significant neurological disorder, including epilepsy/convulsions.

4. Other serious major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.

5. 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.

6. Attempted suicide within 1 year prior to screening, or current suicidal ideation.

7. History of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.

8. A serious illness or infection in the past 30 days as determined by investigator.

9. Clinically significant cognitive dysfunction as determined by investigator.

10. Chronic oxygen therapy.

11. Patients with hypoglossal nerve stimulation implant.

12. Any non-previously mentioned vulnerable population.

13. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SleepRes Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abinash Joshi, MD

Role: PRINCIPAL_INVESTIGATOR

SleepRes Inc.

Locations

SleepCenters of Middle Tennessee

Clarksville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TheraEquivalence

Identifier Type: -

Identifier Source: org_study_id