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A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults (ADAPT-OSA)

29. juni 2026 opdateret af: Sairam Parthasarathy

Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study

Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2400

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center Tucson
        • Ledende efterforsker:
          • Sairam Parthasarathy, MD
        • Kontakt:
        • Underforsker:
          • Saif Mashaqi, MD
        • Underforsker:
          • Monisha Das Ireland, MD
    • California
      • Palo Alto, California, Forenede Stater, 94305
        • Stanford Medical Center
        • Ledende efterforsker:
          • Clete Kushida, MD, PhD
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Miller School of Medicine
        • Underforsker:
          • Alexandre Abreu, MD
        • Kontakt:
        • Ledende efterforsker:
          • Girardin Jean-Louis, PhD
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Emerson Wickwire, PhD
        • Underforsker:
          • Danielle Glick, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Obstructive sleep apnea (AHI >/= 5 per hour), diagnosed in the past 6 months
  • Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness
  • Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)
  • Health insurance of any type

Exclusion Criteria:

  • Prior treatment for OSA in past year
  • Central sleep apnea or narcolepsy
  • Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)
  • Heart failure with reduced ejection fraction of </= 45%
  • Active coronary artery disease (angina or infarction within 3 months of enrollment)
  • Current untreated depression
  • Untreated narrow angle glaucoma
  • Untreated hypothyroidism
  • Clinically significant gastric retention
  • Clinically significant urinary retention
  • History of liver disease
  • Seizure disorder
  • Pregnant or nursing, or plans to become pregnant within the year
  • Concomitant medication use that is incompatible with atomoxetine or oxybutynin
  • Participation in another clinical study with an investigational product

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Positive airway pressure (PAP) therapy
Participants will use a PAP machine to treat their obstructive sleep apnea.
Enhed: Positive airway pressure (PAP) therapy
Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
Andre navne:
  • CPAP
Aktiv komparator: Dental device
Participants will use a sleep dental device to treat their obstructive sleep apnea.
Enhed: Sleep dental device
An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
Andre navne:
  • Mandibular Advancement Device (MAD)
Aktiv komparator: Medications - atomoxetine-oxybutynin
Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
Medicin: Atomoxetine-oxybutynin
The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life
Tidsramme: At 12 months
To compare the effectiveness of positive airway pressure (PAP) therapy versus dental device versus atomoxetine-oxybutynin for key patient centered outcomes in improving health-related quality of life over 12 months, as assessed by the PROMIS-29 v2.0.
At 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
OSA treatment effectiveness - Effective AHI score
Tidsramme: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed by the effective apnea hypopnea index (AHI). Effective AHI equals the sum of apneas and hypopneas with treatment and without treatment divided by hours of total sleep time.
12 months
OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a
Tidsramme: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin for treatment of OSA over 12 months, assessed via the PROMIS-Sleep Related Impairment 8a.
12 months
Changes in systolic blood pressure
Tidsramme: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.
12 months
Changes in diastolic blood pressure
Tidsramme: 12 months
To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.
12 months
OSA treatment adherence
Tidsramme: 12 months
To compare treatment adherence (defined as % of nights assigned treatment was used for 4 or more hours) between PAP therapy versus dental device versus atomoxetine-oxybutynin.
12 months
Adverse effects of OSA treatment
Tidsramme: 12 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
12 months
Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months
Tidsramme: 12 months
Sleep disturbance will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v2.0 scale. The outcome measure is change in PROMIS Sleep Disturbance T-score from baseline to 12 months. PROMIS Sleep Disturbance scores are standardized T-scores referenced to the U.S. general population (mean=50; SD=10) and range from ~ 20 to 80, with higher scores indicating greater sleep disturbance and worse sleep-related symptoms. Negative values for change from baseline indicate improvement in sleep disturbance. Predictors of treatment response will be evaluated using multivariable logistic regression. The dependent variable will be achievement of a clinically meaningful improvement in PROMIS Sleep Disturbance T-score (MCID responder status). Determinants include treatment assignment, age, sex, race/ethnicity, socioeconomic status, insurance status, baseline sleep apnea severity, obesity, & other prespecified determinants.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sairam Parthasarathy

Samarbejdspartnere

Patient-Centered Outcomes Research Institute
University of Miami
University of Maryland
Stanford University
University of Arizona

Efterforskere

  • Ledende efterforsker: Sairam Parthasarathy, MD, University of Arizona

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2030

Studieafslutning (Anslået)

1. maj 2032

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BPS-2024C2-37819

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified outcomes data, including a data dictionary will be made available.

IPD-delingstidsramme

One year after the primary paper has been accepted and secondary paper has been submitted. Data will be available for as long as Dr. Parthasarathy is with the University of Arizona.

IPD-delingsadgangskriterier

Researchers that contact the primary PI (S. Parthasarathy, MD) with a proposal to use the data and complete a data use agreement with the University of Arizona.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Positive airway pressure (PAP) therapy

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