KPAP vs EPR for Comfort

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.

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.

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 positive airway pressure	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
Subjective comfort	This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)	This outcome will be evaluated after 4 days of treatment in each arm

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P95	Pressure delivered by the device for 95% of the time. It will be downloaded from the device.	This outcome will be evaluated after 4 days of treatment in each arm
Residual AHI	Apnea hypopnea index downloaded from the device	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	This outcome will be evaluated after 4 days of treatment in each arm

Collaborators and Investigators

• Sponsor: SleepRes Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 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: Home 0003

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