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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPAP - Experimental Therapy | Experimental | 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. |
|
| CPAP - Traditional OSA Therapy | Active Comparator | Standard OSA therapy to which the TPAP therapy will be compared for efficacy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPAP | Other | 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abinash Joshi, MD | SleepRes Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepCenters of Middle Tennessee | Clarksville | Tennessee | 37043 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: CPAP First TPAP Second | CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow |
| FG001 | Sequence 2: TPAP First CPAP Second | CPAP first: set on P90/P95+1cmH2O TPAP second: two drops of maximum 5cmH2O starting from baseline pressure, one at the start of inspiration, the other at peak inspiratory flow |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This number includes 2 people who were excluded from the final analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Group | The study was a crossover trial of two treatment administered over the same night. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | events/h | During overnight procedure, on average 3.5 hours for each intervention |
|
1 night (half night for each treatment)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insufficient sleep | Nervous system disorders | Non-systematic Assessment | The participant did not get a sufficient sleep time on the treatment arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard Hete | SleepRes | +1 615-921-2406 | bhete@sleepres.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2024 | Nov 21, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Patients will be treated with both the interventional therapy and standard CPAP therapy in one night to compare efficacy.
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Participants will be asleep during both therapies.
|
|
| CPAP | Device | Gold standard for treating sleep apnea. |
|
| 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 |
| Unintentional Patient Circuit Leak | Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak | During overnight procedure |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| P90/P95 | P90/P95 is the positive pressure delivered by the device for 90 or 95% of the night, respectively | Mean | Standard Deviation | cmH2O |
|
| CPAP - Traditional OSA Therapy |
Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea. |
|
|
| 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. | Some people did not have REM sleep, hence the reduced participant sample | Posted | Mean | Standard Deviation | events/h | During rapid eye movements (REM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention |
|
|
|
| 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. | Some people did not sleep in supine position, thus the participant sample is reduced | Posted | Mean | Standard Deviation | events/h | During sleep spent in supine position during the overnight procedure, assessed over 3.5 hours for each intervention |
|
|
|
| Secondary | Unintentional Patient Circuit Leak | Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak | With some machine, it was not possible to determine the leak with precision, hence the reduced participant sample | Posted | Mean | Standard Deviation | L/min | During overnight procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | events/h | During non-rapid eye movements (NREM) sleep during the overnight procedure, assessed over 3.5 hours for each intervention |
|
|
|
| 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 | Some people did not sleep in lateral position, thus the participant sample is reduced | Posted | Mean | Standard Deviation | events/h | During sleep spent in lateral position during the overnight procedure, assessed over 3.5 hours for each intervention |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | CPAP - Traditional OSA Therapy | Standard OSA therapy to which the TPAP therapy will be compared for efficacy. CPAP: Gold standard for treating sleep apnea. | 0 | 50 | 0 | 50 | 0 | 50 |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |