KPAP vs AirSense 11 With EPR

ConditionSleep Apnea, Obstructive

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21-80

SponsorSleepRes Inc.

About this trial

The KPAP vs AirSense 11 with EPR study is a randomized, crossover study in which treatment efficacy will be compared between SleepRes APAP + KPAP and ResMed APAP + EPR. Participants will be chosen from those with a formal OSA diagnosis (following an in-lab polysomnogram, a split-night study or a home sleep apnea test) within the past 2 years and on PAP therapy.

Upon signing an informed consent, participants will be randomized to the order of study and which device will be used first: APAP + KPAP (delivered by a SleepRes device) or APAP + 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. Prior to each overnight, they will have to observe withdrawal of their home PAP treatment for 3 nights. The KPAP drop will be set to the maximum level (i.e., 5 cmH2O), while EPR will be set on 3. APAP from both manufacturers will be set on a 5-20 cmH2O pressure range. 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=APAP+KPAP was extremely better than APAP+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 polysomnograms (by an independent scoring partner, Sleep Strategies) blinded to treatment allocation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI above 18 kg/m2, inclusive

Diagnosis of OSA meeting all the following criteria: AHI4 > 10 on a previous PSG or HST (within the past 2 years), central apneas < 25% of events, PLM arousal index < 15 if recorded

Current treatment with PAP of any nightly duration.

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.

Disqualifiers

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).

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: APAP + KPAPExperimental treatment 1 intervention

Group B: APAP + EPRActive comparator 1 intervention

Trial outcomes