KPAP vs EPR for Comfort
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSleepRes Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
DeviceA 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
DeviceA ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: APAP + KPAPExperimental treatment 1 intervention
Group B: APAP + EPRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Subjective comfort
This outcome will be evaluated through a 10 point Visual Analog Scale (VAS)
Time frame
This outcome will be evaluated after 4 days of treatment in each armSecondary outcomes
1
P95
Pressure delivered by the device for 95% of the time. It will be downloaded from the device.
Time frame
This outcome will be evaluated after 4 days of treatment in each arm2
Residual AHI
Apnea hypopnea index downloaded from the device
Time frame
This outcome will be evaluated after 4 days of treatment in each arm3
Adherence (in average h/night)
Use of the device per night downloaded from the device
Time frame
This outcome will be evaluated after 4 days of treatment in each armLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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