An interventional study of TPAP and CPAP in Obstructive Sleep Apnea, sponsored by SleepRes Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by SleepRes Inc. · Not applicable, Interventional, and Treatment
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's enrollment of 50 is close to the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →SleepRes Inc. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: TPAP
Standard OSA therapy to which the TPAP therapy will be compared for efficacy.
Device: CPAP
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
Also known as: TheraPAP
Gold standard for treating sleep apnea.
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
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
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
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
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
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
| Milestone | Sequence 1: CPAP First TPAP Second | Sequence 2: TPAP First CPAP Second |
|---|---|---|
| Started | 28 | 22 |
| Completed | 26 | 22 |
| Not completed | 2 | 0 |
| Withdrew: Insufficient total sleep time | 1 | 0 |
| Withdrew: Inadequate signal quality | 1 | 0 |
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.
| events/h | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| Apnea/Hypopnea Index | 2.9 ± 4.1 | 3.2 ± 3.9 |
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.
| events/h | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| REM Apnea/Hypopnea Index (AHI) | 4.3 ± 5.1 | 6 ± 6.8 |
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.
| events/h | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| Supine AHI | 4.9 ± 7.5 | 5.4 ± 6.9 |
Evaluation of unintentional circuit leak by measuring flow offset from CPAP and knowing the intentional mask leak
| L/min | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| Unintentional Patient Circuit Leak | 2.8 ± 3.6 | 5.1 ± 4.3 |
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.
| events/h | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| NREM Apnea/Hypopnea Index (AHI) | 2.3 ± 4.4 | 2.2 ± 3.7 |
Assessment of AHI (apnea hypopnea index) during lateral sleep. The device is generally considered efficacious if lateral AHI is below 5 events/h
| events/h | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| Lateral AHI | 2.4 ± 5.4 | 3 ± 5.8 |
Collected over 1 night (half night for each treatment). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TPAP - Experimental Therapy | 0/50 (0%) | 0/50 (0%) | 1/50 (2%) |
| CPAP - Traditional OSA Therapy | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Event | TPAP - Experimental Therapy | CPAP - Traditional OSA Therapy |
|---|---|---|
| Insufficient sleepNervous system disorders | 1/50 | 0/50 |
This number includes 2 people who were excluded from the final analysis
| Age, Continuous(years) | Overall Group |
|---|---|
| Mean | 50 ± 12 |
| Sex: Female, Male(Participants) | Overall Group |
|---|---|
| Female | 26 |
| Male | 24 |
| Race (NIH/OMB)(Participants) | Overall Group |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 5 |
| White | 43 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| P90/P95(cmH2O) | Overall Group |
|---|---|
| Mean | 10.6 ± 2.5 |
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SleepRes Inc.