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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: William H Noah, MD
- Telefonnummer: 6153946624
- E-mail: whnoah@sleepres.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: APAP + KPAP
Autojusterende positiv luftvejstryk + Kairos PAP
|
En SleepRes-enhed vil levere autojusterende positiv luftvejstryk (APAP) + Kairos PAP ved det maksimale fald (1, 2, 3, 4, 5 cmH2O ved baggrundstryk på henholdsvis 6, 7, 8, 9, 10 cmH2O)
|
|
Aktiv komparator: APAP + EPR
Auto-justerende positiv luftvejstryk + Ekspiratorisk tryklettelse
|
Et ResMed-apparat vil levere automatisk justerende positivt luftvejstryk (APAP) + udåndingsrelief indstillet på niveau 3
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Læk
Tidsramme: Dette resultat vil blive evalueret efter én nat med behandling
|
Pr. lækage beregnet af og downloadet fra enheden
|
Dette resultat vil blive evalueret efter én nat med behandling
|
|
Subjektiv søvnkvalitet næste morgen
Tidsramme: Dette resultat vil blive vurderet efter en nat med behandling
|
Per 10-punkts Visuel Analog Skala
|
Dette resultat vil blive vurderet efter en nat med behandling
|
|
Samlet søvntid
Tidsramme: Dette resultat vil blive evalueret efter en nat med behandling
|
Mængde af søvn i minutter bestemt via en polysomnografi i laboratoriet
|
Dette resultat vil blive evalueret efter en nat med behandling
|
|
Søvneffektivitet
Tidsramme: Dette resultat vil blive evalueret efter én nat med behandling
|
Tid sovet divideret med tid i sengen bestemt ved en polysomnografi i laboratoriet
|
Dette resultat vil blive evalueret efter én nat 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
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Ext 0001
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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