Clinical trial NCT06238362: TheraPAP Equivalence Crossover Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: SleepRes Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Apnea/Hypopnea Index
timeFrame: During overnight procedure, on average 3.5 hours for each intervention
Secondary outcomes:
measure: REM Apnea/Hypopnea Index (AHI)
timeFrame: During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
measure: Supine AHI
timeFrame: During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention
measure: Unintentional Patient Circuit Leak
timeFrame: During overnight procedure
measure: NREM Apnea/Hypopnea Index (AHI)
timeFrame: During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
measure: Lateral AHI
timeFrame: During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention
Other outcomes:
Locations:
city: Clarksville
country: United States
facility: SleepCenters of Middle Tennessee
state: Tennessee
Study officials:
affiliation: SleepRes Inc.
name: Abinash Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: