KPAP Adherence Crossover Study

NCT06413134 | Not Yet Recruiting FDA Device

• 1 other identifier: Home 0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A device able to provide less positive airway pressure (PAP) for the entire duration of inspiration and roughly half the duration of expiration, designated KPAP, is being developed by SleepRes for the treatment of obstructive sleep apnea (OSA). In prior studies, the administration of higher inspiratory than expiratory PAP did not substantially increase treatment efficacy or adherence to continuous PAP (CPAP), which remains low. In our recent investigation, we demonstrated that the addition of a resistor to the CPAP circuit to reduce inspiratory PAP increased subjective comfort. In another study, we showed that KPAP improved subjective comfort during wakefulness vs. fixed CPAP, while maintaining treatment efficacy. The present study, KPAP Adherence 1, is a randomized, crossover study designed to examine whether KPAP can improve adherence over APAP as an at home treatment for OSA.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Usage

  Number of hours for which therapy is used per night

  Averaged over every night for each 4-week arm

Secondary Outcomes (5)

• ESS Questionnaire

  Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)

• FOSQ-10 Questionnaire

  Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)

• Excess Leak or Leak

  Averaged over every night for each 4-week arm

• P95/P90

  Averaged over every night for each 4-week arm

• AHI

  Averaged over every night for each 4-week arm

Study Arms (2)

4-weeks breathing on APAP

PLACEBO COMPARATOR

Patients will breathe on APAP for 4 weeks simulating normal therapy. Usage, leak, P95/P90 and AHI will be recorded and averaged over the duration.

Device: APAP

4-weeks breathing on KPAP

EXPERIMENTAL

Patients will breathe on TheraPAP for 4 weeks, which is the therapy under evaluation. Usage, leak, P95/P90 and AHI will also be recorded and averaged over the duration.

Device: KPAP

Interventions

KPAP DEVICE

TheraPAP is a novel CPAP-based therapy in which pressure is dropped as much as 5 cmH2O starting at the beginning of inspiration and extending through the end of expiration where it rises back up to the true therapy pressure for a short period. It improves comfort by providing pressure only when it is needed and maintaining it at a low level the rest of the time. Normal CPAP/APAP therapy keeps pressure at the therapy level during the entire breath cycle, except with some alternate approaches where pressure is decreased but only during the expiratory phase.

4-weeks breathing on KPAP

APAP DEVICE

Standard CPAP therapy where therapy pressure is automatically adjusted to prevent respiratory events from occurring. The TheraPAP prototype device will be used to operate in the APAP mode in addition to the TheraPAP intervention mode.

4-weeks breathing on APAP

Eligibility Criteria

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

You may qualify if:

• AHI \> 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
• Central apneas \< 25% of events
• PLM (Periodic Limb Movements) arousal index \< 15

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).
• Prior therapy or treatment for OSA.
• Chronic oxygen therapy.
• Excessive alcohol consumption (\>14 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.

Sponsors & Collaborators

• SleepRes Inc.: lead

Study Sites (1)

Sleep Centers of Middle Tennessee

Murfreesboro, Tennessee, 37129, United States

Location

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

Study Officials

• William H Noah, MD

  SleepRes, LLC., Sleep Centers of Middle Tennessee, LLC

  STUDY DIRECTOR

Central Study Contacts

Philip Tallent, MD

CONTACT

615-893-4896; gtallent@sleepcenterinfo.com

Bernard Hete, PhD

CONTACT

412-398-2846; bhete@sleepres.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told what therapy they will be using in either arm, and since they are naive to PAP therapy, they would be more blinded than adherent patients.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be two, 4-week arms where patients will breathe on standard APAP therapy and the test therapy, KPAP. Starting therapy will be randomly assigned, but all participants will sleep using both therapies.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 14, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)