KPAP vs AirSense 11 With EPR
A Randomized Crossover Study of Automatic Positive Airway Pressure (APAP) Treatment Efficacy: Kairos APAP (With KPAP) Versus ResMed AirSense APAP With EPR
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: William H Noah, MD
- Telefonnummer: 6153946624
- E-post: whnoah@sleepres.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: APAP + KPAP
Automatisk justerende positivt luftveistrykk + Kairos PAP
|
En SleepRes-enhet vil levere automatisk justerende positivt luftveistrykk (APAP) + Kairos PAP ved maksimalt fall (1, 2, 3, 4, 5 cmH₂O ved bakgrunnstrykk på henholdsvis 6, 7, 8, 9, 10 cmH₂O)
|
|
Aktiv komparator: APAP + EPR
Autojusterende positivt luftveistrykk + Ekspiratorisk trykklettelse
|
Et ResMed-apparat vil levere automatisk justerende positivt luftveistrykk (APAP) + Ekspiratorisk trykkavlastning satt på nivå 3
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment efficacy
Tidsramme: This outcome will be evaluated after one night of treatment
|
Per residual apnea hypopnea 4 (AHI4) index determined through an in-laboratory polysomnography
|
This outcome will be evaluated after one night of treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Leie
Tidsramme: Dette resultatet vil bli evaluert etter én natt med behandling
|
Per lekkasje beregnet av og lastet ned fra enheten
|
Dette resultatet vil bli evaluert etter én natt med behandling
|
|
Subjektiv søvnkvalitet neste morgen
Tidsramme: Dette resultatet vil bli evaluert etter én natts behandling
|
Per 10-punkts visuell analog skala
|
Dette resultatet vil bli evaluert etter én natts behandling
|
|
Total søvntid
Tidsramme: Dette resultatet vil bli evaluert etter én natt med behandling
|
Mengden søvn i minutter bestemt gjennom en polysomnografi i laboratoriet
|
Dette resultatet vil bli evaluert etter én natt med behandling
|
|
Søvneffektivitet
Tidsramme: Dette utfallet vil bli evaluert etter én natt med behandling
|
Tid sovet delt på tid i seng fastsatt gjennom en polisomnografi i laboratorium
|
Dette utfallet vil bli evaluert etter én natt med behandling
|
|
AHI3a
Tidsramme: 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
|
This outcome will be evaluated after one night of treatment
|
|
Next-morning device preference
Tidsramme: This outcome will be evaluated after one night of treatment
|
Per 10-point Visual Analog Scale
|
This outcome will be evaluated after one night of treatment
|
|
P95
Tidsramme: This outcome will be evaluated after one night of treatment
|
Pressure that is delivered by the device for 95% of the usage time
|
This outcome will be evaluated after one night of treatment
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ext 0001
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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