Obstructive Sleep ApneaNCT07530510
KPAP vs EPR for Comfort
A study testing APAP + KPAP and APAP + EPR in people with Obstructive Sleep Apnea, run by SleepRes Inc..
Trial summary
The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve). 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 Jun 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
- 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.
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 Subjective Comfort With At-Home Auto-Titrating Positive Airway Pressure (APAP): Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
The KPAP EPR Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve).
Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.
- 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 positive airway pressure 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.
Subjective comfort
This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)
Measured: This outcome will be evaluated after 4 days of treatment in each arm
Secondary outcomes (3)
P95
Pressure delivered by the device for 95% of the time. It will be downloaded from the device.
Measured: This outcome will be evaluated after 4 days of treatment in each arm
Residual AHI
Apnea hypopnea index downloaded from the device
Measured: This outcome will be evaluated after 4 days of treatment in each arm
Adherence (in average h/night)
Use of the device per night downloaded from the device
Measured: This outcome will be evaluated after 4 days of treatment in each arm
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 Jun 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
- 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
- NCT07530510
- Sponsor's protocol ID
- Home 0003
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study of Subjective Comfort With At-Home Auto-Titrating Positive Airway Pressure (APAP): Kairos PAP (KPAP) Versus Expiratory Pressure Relief (EPR)
- ClinicalTrials.gov ID
- NCT07530510
- Acronym / sponsor ID
- Home 0003
- 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 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (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 Home is a randomized, crossover study in which subjective comfort will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be individuals with newly diagnosed OSA who have not previously tried any PAP treatment (PAP-naïve).
Upon signing an informed consent, participants will be randomized to receiving either APAP + KPAP (delivered by a SleepRes device) or APAP + EPR (delivered by a ResMed device) for home use. Participants will be asked to use the devices (in the order of randomization) for 4 days each, with 3 days of washout in between. Participants will be blinded to the sequence order, even though they will receive machines that are not identical at each treatment. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP will be set on the full pressure range (i.e., 5-20 cmH2O). After each period, each individual will be asked to rate their device preference according to a 10-point visual analog (VAS) scale (i.e., 1=extremely uncomfortable treatment; 10=extremely comfortable treatment). After usage, the devices will be returned to the office and device data will be downloaded.
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 positive airway pressure |
| 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 (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.).
- 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
Subjective comfort
Time frame: This outcome will be evaluated after 4 days of treatment in each arm
This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)
3 secondary outcomes
P95
Time frame: This outcome will be evaluated after 4 days of treatment in each arm
Residual AHI
Time frame: This outcome will be evaluated after 4 days of treatment in each arm
Adherence (in average h/night)
Time frame: This outcome will be evaluated after 4 days of treatment in each 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 15 Apr 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 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 15 Apr 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?
Subjective comfort (time frame: This outcome will be evaluated after 4 days of treatment in each 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 15 Apr 2026.