KPAP vs EPR for Efficacy

NCT07530523 | Not Yet Recruiting FDA Device

• 1 other identifier: Lab 0002
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Treatment efficacy

  Per residual apnea hypopnea index determined through an in-laboratory polysomnography

  This outcome will be evaluated after one night of treatment

Secondary Outcomes (6)

• Leak

  This outcome will be evaluated after one night of treatment

• Next-morning subjective sleep quality

  This outcome will be evaluated after one night of treatment

• Next-morning subjective device preference

  This outcome will be evaluated after one night of treatment

• Sleep onset latency

  This outcome will be evaluated after one night of treatment

• Total sleep time

  This outcome will be evaluated after one night of treatment

Study Arms (2)

APAP + KPAP

EXPERIMENTAL

Auto-adjusting positive airway pressure + Kairos PAP

Device: APAP + KPAP

APAP + EPR

ACTIVE COMPARATOR

Auto-adjusting positive airway pressure + Expiratory Pressure Relief

Device: APAP + EPR

Interventions

APAP + KPAP DEVICE

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 + KPAP

APAP + EPR DEVICE

A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

APAP + EPR

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• SleepRes Inc.: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

William Noah, MD

CONTACT

6153946624; whnoah@sleepres.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Also the scorer of the studies will be blinded to treatment allocation
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share