Sleep Apnea, Obstructive
Conditions
Brief summary
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.
Interventions
DEVICEAPAP + 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)
DEVICEAPAP + EPR
A ResMed device will deliver auto-adjusting positive airway pressure (APAP) + Expiratory Pressure Relief set on level 3
Sponsors
SleepRes Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Also the scorer of the studies will be blinded to treatment allocation
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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. * Prior/Concomitant Therapy including: chronic nocturnal oxygen therapy, mandibular advancement device, active hypoglossal nerve stimulation implant. * Excessive alcohol consumption (\>21 drinks/week). * The use of any illegal drug(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment efficacy | This outcome will be evaluated after one night of treatment | Per residual apnea hypopnea 4 (AHI4) index determined through an in-laboratory polysomnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency | This outcome will be evaluated after one night of treatment | Time asleep divided by time in bed determined through an in-laboratory polysomnography |
| Total sleep time | This outcome will be evaluated after one night of treatment | Amount of sleep in min determined through an in-laboratory polysomnography |
| AHI3a | This outcome will be evaluated after one night of treatment | Residual apnea hypopnea index (calculated with hypopnea associated with 3% desaturations or occurrence of an arousal) determined through an in-laboratory polysomnography |
| Leak | This outcome will be evaluated after one night of treatment | Per leak calculated by and downloaded from the device |
| Next-morning subjective sleep quality | This outcome will be evaluated after one night of treatment | Per 10-point Visual Analog Scale |
| Next-morning device preference | This outcome will be evaluated after one night of treatment | Per 10-point Visual Analog Scale |
| P95 | This outcome will be evaluated after one night of treatment | Pressure that is delivered by the device for 95% of the usage time |
Contacts
CONTACTWilliam H Noah, MD
Outcome results
None listed