TheraPAP Equivalence Crossover Study

Obstructive Sleep Apnea Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238362
• Other study ID #: TheraEquivalence
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: SleepRes Inc.
• Contact: Bernard Hete, PhD
• Phone: 4123982846
• Email: bhete[@]sleepres.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Device:
• CPAP
Gold standard for treating sleep apnea.

Locations

Country	Name	City	State
United States	SleepCenters of Middle Tennessee	Clarksville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
SleepRes Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/Hypopnea Index	Gold standard measure of CPAP therapy efficacy	During overnight procedure
Secondary	Sleep Stage Apnea/Hypopnea Index (AHI)	Assessment of AHI during REM (rapid eye movement) versus non-REM sleep	During overnight procedure
Secondary	Body Position AHI	Assessment of AHI during supine v non-supine sleep	During overnight procedure
Secondary	Unintentional Patient Circuit Leak	Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak	During overnight procedure