Obstructive Sleep ApneaNCT07530523
KPAP vs EPR for Efficacy
A study testing APAP + KPAP and APAP + EPR in people with Obstructive Sleep Apnea, run by SleepRes Inc..
Trial summary
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use… 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?
- APAP + KPAP and APAP + EPR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 31 Dec 2027
- 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
- BMI above 18 kg/m2, inclusive
- Recent formal diagnosis of OSA meeting all the following criteria: AHI > 10, Central apneas < 25% of events, PLM arousal index < 15, no prior/concomitant OSA therapy
- Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
- Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.
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.).
- The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
- A serious illness or infection in the past 30 days.
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- Excessive alcohol consumption (>21 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.
- Chronic nocturnal oxygen therapy.
- Active hypoglossal nerve stimulation implant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Crossover Study of Continuous Positive Airway Pressure (CPAP) Treatment Efficacy: Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use of OS therapy (PAP-naïve).
Upon signing an informed consent, participants will be scheduled to come to the sleep laboratory for a manual titration on CPAP. Once the therapeutic pressure is determined, participants will be randomized to start either CPAP + KPAP (delivered by a SleepRes device) or CPAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization, with a minimum washout of 1 week and a maximum of 3 weeks. Both studies will use the therapeutic pressure determined during manual titration. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed a device subjective preference (1=CPAP+KPAP was extremely better than CPAP+EPR; 10=the opposite).
The study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnographies blinded to treatment allocation.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- APAP + KPAP, APAP + EPR
- 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.
APAP + KPAPDevice
A SleepRes device will deliver auto-adjusting positive airway pressure (APAP) + Kairos PAP at the maximum drop (1, 2, 3, 4, 5 cmH2O at background pressures of 6, 7, 8, 9, 10 cmH2O, respectively)
APAP + EPRDevice
A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3
| Study group | Role | What they receive |
|---|---|---|
| APAP + KPAP | Experimental | Auto-adjusting positive airway pressure + Kairos PAP Receives: Device: APAP + KPAP |
| APAP + EPR | Active comparator | Auto-adjusting positive airway pressure + Expiratory Pressure Relief Receives: Device: APAP + EPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy
Per residual apnea hypopnea index determined through an in-laboratory polysomnography
Measured: This outcome will be evaluated after one night of treatment
Secondary outcomes (6)
Leak
Per leak calculated by and downloaded from the device
Measured: This outcome will be evaluated after one night of treatment
Next-morning subjective sleep quality
Per 10-point Visual Analog Scale
Measured: This outcome will be evaluated after one night of treatment
Next-morning subjective device preference
Per 10-point Visual Analog Scale
Measured: This outcome will be evaluated after one night of treatment
Sleep onset latency
Time that it takes for sleep to onset determined through an in-laboratory polysomnography
Measured: This outcome will be evaluated after one night of treatment
Total sleep time
Amount of sleep in min determined through an in-laboratory polysomnography
Measured: This outcome will be evaluated after one night of treatment
Sleep efficiency
Time asleep divided by time in bed determined through an in-laboratory polysomnography
Measured: This outcome will be evaluated after one night of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SleepRes Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530523
- Sponsor's protocol ID
- Lab 0002
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We only plan to share the results after we publish them
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study of Continuous Positive Airway Pressure (CPAP) Treatment Efficacy: Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
- ClinicalTrials.gov ID
- NCT07530523
- Acronym / sponsor ID
- Lab 0002
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- SleepRes Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Apr 2026 (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.
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR. Participants will be chosen from those with a recent OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) and with no previous use of OS therapy (PAP-naïve).
Upon signing an informed consent, participants will be scheduled to come to the sleep laboratory for a manual titration on CPAP. Once the therapeutic pressure is determined, participants will be randomized to start either CPAP + KPAP (delivered by a SleepRes device) or CPAP + EPR (delivered by a ResMed device). Participants will be blinded to the sequence order. They will then be invited to the laboratory for two overnight sleep studies, one on each treatment device, in the order determined by the randomization, with a minimum washout of 1 week and a maximum of 3 weeks. Both studies will use the therapeutic pressure determined during manual titration. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. The next morning of each sleep study, participants will be administered visual analog scale (VAS) questionnaires to examine subjective sleep quality (1=best sleep quality; 10=worst sleep quality) and, after all studies are completed a device subjective preference (1=CPAP+KPAP was extremely better than CPAP+EPR; 10=the opposite).
The study will be single blinded with both the participants (the device will be concealed in the laboratory so that participants will not be able to understand what treatment they are on) and the registered technician scoring the polysomnographies blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APAP + KPAP | Experimental | Device: APAP + KPAPAuto-adjusting positive airway pressure + Kairos PAP |
| APAP + EPR | Active comparator | Device: APAP + EPRAuto-adjusting positive airway pressure + Expiratory Pressure Relief |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI above 18 kg/m2, inclusive
- Recent formal diagnosis of OSA meeting all the following criteria: AHI > 10, Central apneas < 25% of events, PLM arousal index < 15, no prior/concomitant OSA therapy
- Subject is fluent in English and subject understands the study protocol and is willing and able to comply with study requirements and sign informed consent.
- Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the study-related procedures.
Key exclusion criteria (11 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.).
- The presence of a psychiatric disorder, including attempted suicide within 1 year prior to screening, or current suicidal ideation.
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 |
|---|---|---|
| APAP + KPAPA SleepRes device will deliver auto-adjusting positive airway pressure (APAP) + Kairos PAP at the maximum drop (1, 2, 3, 4, 5 cmH2O at background pressures of 6, 7, 8, 9, 10 cmH2O, respectively) | Device | APAP + KPAP |
| APAP + EPRA ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3 | Device | APAP + EPR |
Primary outcome
Treatment efficacy
Time frame: This outcome will be evaluated after one night of treatment
Per residual apnea hypopnea index determined through an in-laboratory polysomnography
6 secondary outcomes
Leak
Time frame: This outcome will be evaluated after one night of treatment
Next-morning subjective sleep quality
Time frame: This outcome will be evaluated after one night of treatment
Next-morning subjective device preference
Time frame: This outcome will be evaluated after one night of treatment
Sleep onset latency
Time frame: This outcome will be evaluated after one night of treatment
Total sleep time
Time frame: This outcome will be evaluated after one night of treatment
Sleep efficiency
Time frame: This outcome will be evaluated after one night of treatment
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 4 Aug 2026.
- Individual participant dataSharing planned: No. We only plan to share the results after we publish them
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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.
Questions about this trial
What is this clinical trial studying?
A study testing APAP + KPAP and APAP + EPR in people with Obstructive Sleep Apnea, run by SleepRes Inc..
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 4 inclusion and 11 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 William Noah, MD (6153946624, whnoah@sleepres.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: This outcome will be evaluated after one night of treatment). 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 4 Aug 2026.