Obstructive Sleep Apnea
Conditions
Keywords
CPAP, comfort
Brief summary
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.
Detailed description
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.
Interventions
DEVICETPAP
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.
DEVICECPAP
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.
Sponsors
SleepRes Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 - 70 age range * AHI (apnea/hypopnea index) \> 10 on a previous HST (Home Sleep Test) * CPAP-naive participants * BMI (Body Mass Index) \>= 18 kg/m\^2
Exclusion criteria
1. Current clinically significant sleep disorder other than OSA (Obstructive Sleep Apnea) of a severity that would interfere with study participation or interpretability of data (including central sleep apnea, per central AHI \> 5 events/h). 2. Any chronic lung diseases. 3. Chronic oxygen therapy. 4. A serious illness or infection in the past 30 days as determined by investigator. 5. Patients with hypoglossal nerve stimulation implant. 6. Any non-previously mentioned vulnerable population. 7. 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 |
|---|---|---|
| CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. | Compare the comfort level of CPAP at 9 cmH2O against TPAP dropped by 2+2 cmH2O |
| CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O | All tests conducted in a 20 minute time frame on awake supine patients. | Compare the comfort level of CPAP at 13 cmH2O against TPAP dropped by 2+3 cmH2O |
Secondary
| Measure | 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Group All participants in the study (who crossovered from one treatment arm to the other) | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Overall Group |
|---|---|
| Age, Continuous | 43 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 123 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
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
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: The outcome refers to % of participants who preferred TPAP over CPAP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+3 cmH2O | 84 percentage of total participants |
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
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: The outcome refers to % of participants who preferred TPAP over CPAP
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | 69.3 percentage of total participants |
Secondary
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | 38.5 percentage of total participants |
Secondary
CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 13 cmH2O Baseline Pressure, TPAP Drop 2+2 cmH2O | 45.8 percentage of total participants |
Secondary
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+1 cmH2O | 56 percentage of total participants |
Secondary
CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O
Time frame: All tests conducted in a 20 minute time frame on awake supine patients.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CPAP vs. TPAP (Baseline Pressure: 9 cmH2O ) | CPAP v TPAP Patient Preference at 9 cmH2O Baseline Pressure, TPAP Drop 1+2 cmH2O | 45.6 percentage of total participants |