Obstructive Sleep Apnea
Conditions
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.
Interventions
OTHERTPAP
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
DEVICECPAP
Gold standard for treating sleep apnea.
Sponsors
SleepRes Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be asleep during both therapies.
Intervention model description
Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea/Hypopnea Index | During overnight procedure, on average 3.5 hours for each intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| REM Apnea/Hypopnea Index (AHI) | During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention | 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. |
| Supine AHI | During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention | 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. |
| Unintentional Patient Circuit Leak | During overnight procedure | Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak |
| NREM Apnea/Hypopnea Index (AHI) | During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention | 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. |
| Lateral AHI | During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention | Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Group The study was a crossover trial of two treatment administered over the same night. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inadequate signal quality | 1 | 0 |
| Overall Study | Insufficient total sleep time | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Group |
|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12 |
| P90/P95 | 10.6 cmH2O STANDARD_DEVIATION 2.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 1 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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.
Time frame: During overnight procedure, on average 3.5 hours for each intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | Apnea/Hypopnea Index | 2.9 events/h | Standard Deviation 4.1 |
| CPAP - Traditional OSA Therapy | Apnea/Hypopnea Index | 3.2 events/h | Standard Deviation 3.9 |
Secondary
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
Time frame: During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention
Population: Some people did not sleep in lateral position, thus the participant sample is reduced
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | Lateral AHI | 2.4 events/h | Standard Deviation 5.4 |
| CPAP - Traditional OSA Therapy | Lateral AHI | 3 events/h | Standard Deviation 5.8 |
Secondary
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.
Time frame: During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | NREM Apnea/Hypopnea Index (AHI) | 2.3 events/h | Standard Deviation 4.4 |
| CPAP - Traditional OSA Therapy | NREM Apnea/Hypopnea Index (AHI) | 2.2 events/h | Standard Deviation 3.7 |
Secondary
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.
Time frame: During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention
Population: Some people did not have REM sleep, hence the reduced participant sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | REM Apnea/Hypopnea Index (AHI) | 4.3 events/h | Standard Deviation 5.1 |
| CPAP - Traditional OSA Therapy | REM Apnea/Hypopnea Index (AHI) | 6 events/h | Standard Deviation 6.8 |
Secondary
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.
Time frame: During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention
Population: Some people did not sleep in supine position, thus the participant sample is reduced
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | Supine AHI | 4.9 events/h | Standard Deviation 7.5 |
| CPAP - Traditional OSA Therapy | Supine AHI | 5.4 events/h | Standard Deviation 6.9 |
Secondary
Unintentional Patient Circuit Leak
Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak
Time frame: During overnight procedure
Population: With some machine, it was not possible to determine the leak with precision, hence the reduced participant sample
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPAP - Experimental Therapy | Unintentional Patient Circuit Leak | 2.8 L/min | Standard Deviation 3.6 |
| CPAP - Traditional OSA Therapy | Unintentional Patient Circuit Leak | 5.1 L/min | Standard Deviation 4.3 |