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TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what is called TPAP . TPAP is a pressure control algorithm that lowers the pressure from the set pressure at the beginning of inspiration and does not return the pressure to the full set level until about halfway through expiration. The present study, TheraPAP Comfort, aims at assessing whether TPAP improves patient comfort vs. CPAP during supine wakefulness.
The TheraPAP Comfort Study is an in-office study to assess comfort of TPAP vs. CPAP in CPAP-naïve patients with OSA during supine wakefulness. Patients will be recruited after routine outpatient visits. They will be asked to breath normally for approximately 1 minute in supine wakefulness while being administered background CPAP (at 9 or 13 cmH2O) or TPAP at various pressure drops. TPAP drops will be administered in a paired comparison before or/and after each corresponding CPAP level, according to a randomized design. Eventually, 6 one-to-one comparisons (TPAP vs. corresponding background CPAP or TPAP vs. TPAP) will be made, 3 per each randomized order. As an example, CPAP 9 will be compared to TPAP 1/1 cmH2O drops; CPAP 9 will be compared to TPAP 2/2 cmH2O drops; and TPAP 1/1 cmH2O drops will be compared to TPAP 2/2 cmH2O drops in a random sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP v TPAP | Experimental | Participants will compare CPAP to 2 different levels of TPAP, then will compare 2 levels of TPAP against each other by breathing on each pair of therapies for a minute or so, then deciding which is more comfortable or if they are equivalent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPAP | Device | TPAP is a form of CPAP therapy where the therapy pressure is reduced from the beginning of inhalation through mid or later exhalation. The "CPAP" therapy pressure is only present at the end of the expiratory phase. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. |
| CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O | Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. | |
| CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abinash Joshi, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SleepCenters of Middle Tennessee | Murfreesboro | Tennessee | 37129 | United States |
We only plan to share the results after we publish them.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Period 1: CPAP Period 2: TPAP This was a trial in which the same participant underwent multiple testing in sequence and on the same session after being randomized only once (to CPAP or TPAP first). As such, only two sequences are present. CPAP was initially administered at 9 cmH2O TPAP was initially reduced by 2+2 cmH2O If the participant chose TPAP, the test was repeated as follows (see also below): CPAP was administered at 13 cmH2O TPAP was reduced by 2+3 cmH2O If the participant chose TPAP, testing ended. If the participant, instead, had chosen CPAP at 9 cmH2O, the test was repeated as follows: CPAP was administered at 9 cmH2O TPAP was reduced by 1+2 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 9 cmH2O, the test was repeated as follows: CPAP was administered at 9 cmH2O TPAP was reduced by 1+1 cmH2O Regardless, of the choice, the testing was repeated as follows: CPAP was administered at 13 cmH2O TPAP was reduced by 2+3 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 13 cmH2O, testing was repeated as follows: CPAP was administered at 13 cmH2O TPAP was reduced by 2+2 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 13 cmH2O, testing was repeated as follows: CPAP was administered at 13 cmH2O TPAP was reduced by 1+2 cmH2O Regardless of choices, testing ended after this. |
| FG001 | Sequence 2 | Period 1: TPAP Period 2: CPAP This was a trial in which the same participant underwent multiple testing in sequence and on the same session after being randomized only once (to CPAP or TPAP first). As such, only two sequences are present. TPAP was initially reduced by 2+2 cmH2O CPAP was initially administered at 9 cmH2O If the participant chose TPAP, the test was repeated as follows (see also below): TPAP was reduced by 2+3 cmH2O CPAP was administered at 13 cmH2O If the participant chose TPAP, testing ended. If the participant, instead, had chosen CPAP at 9 cmH2O, the test was repeated as follows: TPAP was reduced by 1+2 cmH2O CPAP was administered at 9 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 9 cmH2O, the test was repeated as follows: TPAP was reduced by 1+1 cmH2O CPAP was administered at 9 cmH2O Regardless, of the choice, the testing was repeated as follows: TPAP was reduced by 2+3 cmH2O CPAP was administered at 13 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 13 cmH2O, testing was repeated as follows: TPAP was reduced by 2+2 cmH2O CPAP was administered at 13 cmH2O If the participant chose TPAP, testing ended. If the participant chose CPAP at 13 cmH2O, testing was repeated as follows: TPAP was reduced by 1+2 cmH2O CPAP was administered at 13 cmH2O Regardless of choices, testing ended after this. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Group | All participants in the study (who crossovered from one treatment arm to the other) |
| Units | Counts |
|---|---|
| Participants |
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| 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 | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O | The outcome refers to % of participants who preferred TPAP over CPAP | Posted | Number | 95% Confidence Interval | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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20 minute office visit
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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 | TPAP group at baseline pressure of 9 or 13 cmH2O. Testing was done in series within the same sequence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernie 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 23, 2024 | Nov 14, 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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All participants will undergo the same therapy combinations. CPAP (Continuous Positive Airway Pressure) and 2 level of TPAP (TheraPAP - novel CPAP approach pressure is reduced below therapy pressure from inspiration through mid exhalation specifically for comfort) will be assessed against each other in a round robin both backward and forward (6 total binary comparisons) for 2 levels of baseline pressure.
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There is no specific intent to mask although participants will be naive to CPAP-type therapy, but they will be able to feel the difference.
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| CPAP | Device | CPAP is a standard formal at home therapy for obstructive sleep apnea where a device attached via a facemask applies a constant pressure to a patient's lungs during sleep. It is the reference standard in this study. |
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| CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. |
| CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O | Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O | The outcome refers to % of participants who preferred TPAP over CPAP | Posted | Number | 95% Confidence Interval | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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| Secondary | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | The outcome data refers to participants (N=21) who preferred TPAP (with a 1+2 cmH2O drop) over CPAP at 9 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 9 cmH2O and TPAP with a 2+2 cmH2O, independent of sequence. I.e., 46 participants found CPAP more comfortable than TPAP with 2+2 cmH2O drop, so testing continued with those individuals, of whom, eventually, 21 chose TPAP with 1+2 cmH2O drop. | Posted | Number | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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| Secondary | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O | The outcome data refers to participants (N=14) who preferred TPAP (with a 1+1 cmH2O drop) over CPAP at 9 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 9 cmH2O and TPAP with a 2+2 cmH2O or with at 1+2 cmH2O drop, independent of sequence. I.e., only 25 participants found CPAP more comfortable than TPAP at any drop, so testing continued with those individuals, of whom, eventually, 14 chose TPAP with 1+1 cmH2O drop. | Posted | Number | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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| Secondary | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | The outcome data refers to participants (N=11) who preferred TPAP (with a 2+2 cmH2O drop) over CPAP at 13 cmH2O. Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 13 cmH2O and TPAP with a 2+3 cmH2O, independent of sequence. I.e., only 24 participants found CPAP more comfortable than TPAP with 2+3 cmH2O drop, so testing continued with those individuals, of whom, eventually, 11 chose TPAP with 2+2 cmH2O drop. | Posted | Number | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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| Secondary | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | The outcome data refers to participants (N=5) who preferred TPAP (with a 1+2 cmH2O drop) over CPAP at 13 cmH2O.Notably, this was a repeated test among participants who initially did not prefer TPAP in the comparison between CPAP at 13 cmH2O and TPAP with a 2+3 cmH2O or with at 2+2 cmH2O drop, independent of sequence. I.e., only 13 participants found CPAP more comfortable than TPAP at any drop, so testing continued with those individuals, of whom, eventually, 5 chose TPAP with 1+2 cmH2O drop | Posted | Number | percentage of total participants | All tests conducted in a 20 minute time frame on awake supine patients. |
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| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | CPAP | CPAP group at baseline pressure of 9 or 13 cmH2O. Testing was done in series within the same sequence | 0 | 150 | 0 | 150 | 0 | 150 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |