N/A
N=50
TheraPAP Equivalence Crossover Study
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT06238362 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Apnea/Hypopnea Index — 2.9; 3.2 events/h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TPAP (Other); CPAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SleepRes Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea/Hypopnea Index |
2.9; 3.2 | — |
| SECONDARY REM Apnea/Hypopnea Index (AHI) |
4.3; 6 | — |
| SECONDARY Supine AHI |
4.9; 5.4 | — |
| SECONDARY Unintentional Patient Circuit Leak |
2.8; 5.1 | — |
| SECONDARY NREM Apnea/Hypopnea Index (AHI) |
2.3; 2.2 | — |
| SECONDARY Lateral AHI |
2.4; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06238362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.