TheraPAP Equivalence Crossover Study

Randomized Crossover Study to Compare Effectiveness of a Device Providing Pressure Drops During Inspiration (TPAP) to Continuous Positive Airway Pressure (CPAP) in Obstructive Sleep Apnea (OSA)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: TPAP; Device: CPAP

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Clarksville, Tennessee, United States, 37043
      • SleepCenters of Middle Tennessee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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; Other Names: TheraPAP
Active Comparator: CPAP - Traditional OSA Therapy; Standard OSA therapy to which the TPAP therapy will be compared for efficacy.	Device: CPAP; Gold standard for treating sleep apnea.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unintentional Patient Circuit Leak	Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak	During overnight procedure
REM Apnea/Hypopnea Index (AHI)	Scored as number of respiratory events per hour of sleep spent in rapid eye movement stage. The device is generally considered efficacious with an apnea-hypopnea index in REM < 5 events/h, however it has to be noted that obstructive sleep apnea during REM sleep is more difficult to treat.	During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Supine AHI	Assessment of AHI (apnea hypopnea index) during supine sleep. The device is generally considered efficacious if supine AHI is below 5 events/h, however it has to be noted that obstructive sleep apnea in supine position is more difficult to treat.	During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention
NREM Apnea/Hypopnea Index (AHI)	Scored as number of respiratory events per hour of sleep spent in non-rapid eye movement stage (NREM). The device is generally considered efficacious with an apnea-hypopnea index in NREM < 5 events/h.	During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Lateral AHI	Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h	During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention

Collaborators and Investigators

• Sponsor: SleepRes Inc.
• Investigators: Principal Investigator: Abinash Joshi, MD, SleepRes Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: TheraEquivalence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No