KPAP Adherence Crossover Study
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorSleepRes Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
AHI > 10 on a previous PSG or HST (hypopneas requiring 4% desaturation).
Central apneas < 25% of events
PLM (Periodic Limb Movements) arousal index < 15
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
KPAP
DeviceTheraPAP 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.
APAP
DeviceStandard 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 4-weeks breathing on APAPPlacebo comparator 1 intervention
Group B: 4-weeks breathing on KPAPExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Usage
Number of hours for which therapy is used per night
Time frame
Averaged over every night for each 4-week armSecondary outcomes
1
ESS Questionnaire
Epworth Sleepiness Scale - a standard questionnaire to assess sleep quality. Scoring goes from 0 to 24 and higher scores means worsening sleepiness.
Time frame
Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)2
FOSQ-10 Questionnaire
Functional Outcomes of Sleep Questionnaire - 10 - a standard questionnaire to assess sleep quality. Scoring goes from 10 to 40 and higher scores means better functional outcome.
Time frame
Filled out twice, once after completion of each 4-week arm (at week 4 and at week 9)3
Excess Leak or Leak
Excess leak is patient circuit leak in excess of the normal leak required to prevent rebreathing in a CPAP device, which exits the circuit from the exhaust valve. Examples of excess leak include mask sealing leak or mouth opening. This excess leak will be averaged per night.
Time frame
Averaged over every night for each 4-week arm4
P95/P90
Standard CPAP measurement - pressure levels that eliminate breathing obstructions for at least 90% to 95% of the sleep period
Time frame
Averaged over every night for each 4-week armSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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