Obstructive Sleep ApneaNCT06413134
KPAP Adherence Crossover Study
A study testing KPAP and APAP in people with Obstructive Sleep Apnea, run by SleepRes Inc. at 1 site in United States.
Trial summary
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- KPAP and APAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
- Central apneas < 25% of events
- PLM (Periodic Limb Movements) arousal index < 15
Who cannot join
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
- The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).
- Prior therapy or treatment for OSA.
- Chronic oxygen therapy.
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- Excessive alcohol consumption (>14 drinks/week).
- The use of any illegal drug(s).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, 37129
Craig Salazar, 615-893-4896, csalazar@sleepcenterinfo.com
Bernard Hete, PhD
About this study
Official title: A Prospective, Randomized, Crossover Study of Therapy Adherence With Kairos Positive Airway Pressure (KPAP) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.
Read the detailed description
The KPAP Adherence 1 is a randomized, crossover study in which the adherence to therapy will be compared between KPAP and standard APAP. Participants will be chosen from a pool of patients who are PAP-naïve and who have received either a PSG (in-lab polysomnogram), split-night study (in-lab PSG and pressure titration) or home sleep study (HST) within the previous 3 months.
Upon signing an informed consent, participants will be randomly assigned to start on either the KPAP (supplied by a SleepRes device) or the APAP (supplied by a ResMed device) arm when they arrive at the office. Each participant will then be given their new equipment and will be trained in proper use of the device assigned for the first treatment arm. The device will be used at home, nightly, for 4 weeks. Afterward, they will return to the office for their second visit. They will then be given the other device-along with the appropriate explanation on how to use it-that they will use on their second treatment arm. Subsequently, they will undergo a washout period of 1 week where no therapy will be used. Following the washout period, they will initiate another 4-week usage with the second therapy device. At the end of the second 4-week period, participants will return to the office for their third visit.
In both the APAP and KPAP arms, participants will have their therapy set to 5-20 cmH2O for one week. The pressure range will then be narrowed to ± 2 cmH2O around their 95% pressure level as assessed during the first week. This same pressure range will be used during the second arm for each patient.
During the KPAP arm, participants will be set to a double Comfort Setting drop according to the following scheme. This drop schedule will be implemented while the KPAP device is operating with automatic pressure adjustment.
Pset Drop 1 Drop 2 5.0 - 5.9 0 0 6.0 - 6.9 1 0 7.0 - 7.9 2 0 8.0 - 8.9 2 1 9.0 - 9.9 2 2 10.0 - 20.0 2 3
Phone calls to encourage use and assess adherence and side effects will be made at different time points during both treatment arms. Subjects using the device less than an average of 5 hours per night during the first week will be contacted on a more regular basis (weekly until 5 hour per night use is achieved) to address any problems and encourage use. If participants discontinue the use of the device during the home use period, they will still be encouraged to return for all testing per protocol. If a patient refuses to come in for further testing, they will be considered a lost to follow up and excluded from efficacy analysis.
- 1 Day Phone Call (+2 days)
- 7 Day Phone Call (+/- 3 days)
- 14 Day Phone Call (+/- 3 days)
- 21 Day Phone Call (+/- 3 days) to remind participants and schedule the office visit and device return on day 28
- Equipment Return
After each arm, the patient will return to the office for the after-treatment visit (Visit 2 and Visit 3) to record the following:
- Adverse Event Assessment
- PROMIS Fatigue
- Epworth Sleepiness Scale (ESS)
- Functional Outcomes of Sleep Questionnaire (FOSQ)
- Short Form 36 (SF36)
- Comfort and Satisfaction, per Visual analog Scale (VAS)
- Nightly adherence recording
Data collected from the therapy device will include the following:
- Usage averaged over the 4-week period and nightly
- Leak averaged over the 4-week period and nightly
- P95 averaged over the 4-week period and nightly
- Sleep events averaged over the 4-week period and nightly
- Conditions
- Obstructive Sleep Apnea
- Being tested
- KPAP, APAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPAPDevice
TheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP/APAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase.
APAPDevice
Standard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode.
| Study group | Role | What they receive |
|---|---|---|
| 4-weeks breathing on APAP | Placebo comparator | Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration. Receives: Device: APAP |
| 4-weeks breathing on KPAP | Experimental | Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration. Receives: Device: KPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage
Number of hours for which therapy is used per night
Measured: Averaged over every night for each 4-week arm
Secondary outcomes (5)
ESS Questionnaire
Epworth Sleepiness Scale - a standard questionnaire to assess sleep quality. Scoring goes from 0 to 24 and higher scores means worsening sleepiness.
Measured: Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)
FOSQ-10 Questionnaire
Functional Outcomes of Sleep Questionnaire - 10 - a standard questionnaire to assess sleep quality. Scoring goes from 10 to 40 and higher scores means better functional outcome.
Measured: Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)
Excess Leak or Leak
Excess leak is patient circuit leak in excess of the normal leak required to prevent rebreathing in a CPAP device, which exits the circuit from the exhaust valve. Examples of excess leak include mask sealing leak or mouth opening. This excess leak will be averaged per night.
Measured: Averaged over every night for each 4-week arm
P95/P90
Standard CPAP measurement - pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period
Measured: Averaged over every night for each 4-week arm
AHI
Apnea/Hypopnea Index - measure of the number of obstructive breathing events per hour experienced by the patient
Measured: Averaged over every night for each 4-week arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There will be two, 4-week arms where patients will breathe on standard APAP therapy and the test therapy, KPAP. Starting therapy will be randomly assigned, but all participants will sleep using both therapies.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SleepRes Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William H Noah, MD, Study director, SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413134
- Sponsor's protocol ID
- Home 0001
- Status last verified
- May 2026
- First submitted
- 3 May 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Crossover Study of Therapy Adherence With Kairos Positive Airway Pressure (KPAP) Compared to Automatic Adjusting Positive Airway Pressure (APAP) for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06413134
- Acronym / sponsor ID
- Home 0001
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SleepRes Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.
Detailed description
The KPAP Adherence 1 is a randomized, crossover study in which the adherence to therapy will be compared between KPAP and standard APAP. Participants will be chosen from a pool of patients who are PAP-naïve and who have received either a PSG (in-lab polysomnogram), split-night study (in-lab PSG and pressure titration) or home sleep study (HST) within the previous 3 months.
Upon signing an informed consent, participants will be randomly assigned to start on either the KPAP (supplied by a SleepRes device) or the APAP (supplied by a ResMed device) arm when they arrive at the office. Each participant will then be given their new equipment and will be trained in proper use of the device assigned for the first treatment arm. The device will be used at home, nightly, for 4 weeks. Afterward, they will return to the office for their second visit. They will then be given the other device-along with the appropriate explanation on how to use it-that they will use on their second treatment arm. Subsequently, they will undergo a washout period of 1 week where no therapy will be used. Following the washout period, they will initiate another 4-week usage with the second therapy device. At the end of the second 4-week period, participants will return to the office for their third visit.
In both the APAP and KPAP arms, participants will have their therapy set to 5-20 cmH2O for one week. The pressure range will then be narrowed to ± 2 cmH2O around their 95% pressure level as assessed during the first week. This same pressure range will be used during the second arm for each patient.
During the KPAP arm, participants will be set to a double Comfort Setting drop according to the following scheme. This drop schedule will be implemented while the KPAP device is operating with automatic pressure adjustment.
Pset Drop 1 Drop 2 5.0 - 5.9 0 0 6.0 - 6.9 1 0 7.0 - 7.9 2 0 8.0 - 8.9 2 1 9.0 - 9.9 2 2 10.0 - 20.0 2 3
Phone calls to encourage use and assess adherence and side effects will be made at different time points during both treatment arms. Subjects using the device less than an average of 5 hours per night during the first week will be contacted on a more regular basis (weekly until 5 hour per night use is achieved) to address any problems and encourage use. If participants discontinue the use of the device during the home use period, they will still be encouraged to return for all testing per protocol. If a patient refuses to come in for further testing, they will be considered a lost to follow up and excluded from efficacy analysis.
- 1 Day Phone Call (+2 days)
- 7 Day Phone Call (+/- 3 days)
- 14 Day Phone Call (+/- 3 days)
- 21 Day Phone Call (+/- 3 days) to remind participants and schedule the office visit and device return on day 28
- Equipment Return
After each arm, the patient will return to the office for the after-treatment visit (Visit 2 and Visit 3) to record the following:
- Adverse Event Assessment
- PROMIS Fatigue
- Epworth Sleepiness Scale (ESS)
- Functional Outcomes of Sleep Questionnaire (FOSQ)
- Short Form 36 (SF36)
- Comfort and Satisfaction, per Visual analog Scale (VAS)
- Nightly adherence recording
Data collected from the therapy device will include the following:
- Usage averaged over the 4-week period and nightly
- Leak averaged over the 4-week period and nightly
- P95 averaged over the 4-week period and nightly
- Sleep events averaged over the 4-week period and nightly
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two, 4-week arms where patients will breathe on standard APAP therapy and the test therapy, KPAP. Starting therapy will be randomly assigned, but all participants will sleep using both therapies.
| Arm | Type | Receives |
|---|---|---|
| 4-weeks breathing on APAP | Placebo comparator | Device: APAPPatients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration. |
| 4-weeks breathing on KPAP | Experimental | Device: KPAPPatients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI > 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
- Central apneas < 25% of events
- PLM (Periodic Limb Movements) arousal index < 15
Key exclusion criteria (9 listed)
- A female of child-bearing potential that is pregnant or intends to become pregnant.
- Any unstable or severe medical condition of any organ system including congestive heart failure, COPD, renal failure, neuromuscular disease, etc., or at the discretion of the site Principal Investigator (PI).
- Taking medication that may affect sleep, sleepiness, or alertness including hypnotics, sedatives, alerting agents, stimulants, anticonvulsants, etc.
- The presence of any other sleep disorder (insomnia, periodic limb movement disorder, etc).
- Prior therapy or treatment for OSA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KPAPTheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP/APAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase. | Device | 4-weeks breathing on KPAP |
| APAPStandard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode. | Device | 4-weeks breathing on APAP |
Primary outcome
Usage
Time frame: Averaged over every night for each 4-week arm
Number of hours for which therapy is used per night
5 secondary outcomes
ESS Questionnaire
Time frame: Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)
FOSQ-10 Questionnaire
Time frame: Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)
Excess Leak or Leak
Time frame: Averaged over every night for each 4-week arm
P95/P90
Time frame: Averaged over every night for each 4-week arm
AHI
Time frame: Averaged over every night for each 4-week arm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William H Noah, MD study director
SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KPAP and APAP in people with Obstructive Sleep Apnea, run by SleepRes Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Tallent, MD (615-893-4896, gtallent@sleepcenterinfo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage (time frame: Averaged over every night for each 4-week arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.