KPAP vs EPR for Efficacy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: APAP + KPAP; Device: APAP + EPR

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Noah, MD; Phone Number: 6153946624; Email: whnoah@sleepres.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APAP + KPAP; Auto-adjusting positive airway pressure + Kairos PAP	Device: APAP + KPAP; 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)
Active Comparator: APAP + EPR; Auto-adjusting positive airway pressure + Expiratory Pressure Relief	Device: APAP + EPR; A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment efficacy	Per residual apnea hypopnea index determined through an in-laboratory polysomnography	This outcome will be evaluated after one night of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leak	Per leak calculated by and downloaded from the device	This outcome will be evaluated after one night of treatment
Next-morning subjective sleep quality	Per 10-point Visual Analog Scale	This outcome will be evaluated after one night of treatment
Next-morning subjective device preference	Per 10-point Visual Analog Scale	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	This outcome will be evaluated after one night of treatment
Total sleep time	Amount of sleep in min determined through an in-laboratory polysomnography	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	This outcome will be evaluated after one night of treatment

Collaborators and Investigators

• Sponsor: SleepRes Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: Lab 0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We only plan to share the results after we publish them

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No