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)
2026년 6월 29일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
2400
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Heidi Erickson, BSN, RN
- 전화번호: 1-520-626-5287
- 이메일: herickso@arizona.edu
연구 장소
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Arizona
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Tucson, Arizona, 미국, 85719
- Banner University Medical Center Tucson
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수석 연구원:
- Sairam Parthasarathy, MD
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연락하다:
- Nayeli Lopez
- 전화번호: 1-520-626-6453
- 이메일: nayelij@arizona.edu
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부수사관:
- Saif Mashaqi, MD
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부수사관:
- Monisha Das Ireland, MD
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California
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Palo Alto, California, 미국, 94305
- Stanford Medical Center
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수석 연구원:
- Clete Kushida, MD, PhD
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Florida
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Miami, Florida, 미국, 33136
- University of Miami Miller School of Medicine
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부수사관:
- Alexandre Abreu, MD
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연락하다:
- Nina L'Houtellier
- 전화번호: 1-305-689-1358
- 이메일: nvl15@med.miami.edu
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수석 연구원:
- Girardin Jean-Louis, PhD
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Maryland
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Baltimore, Maryland, 미국, 21201
- University of Maryland Medical Center
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연락하다:
- Christine Johnston
- 전화번호: 1-410-706-7853
- 이메일: christine.johnston@som.umaryland.edu
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수석 연구원:
- Emerson Wickwire, PhD
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부수사관:
- Danielle Glick, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Positive airway pressure (PAP) therapy
Participants will use a PAP machine to treat their obstructive sleep apnea.
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Positive airway pressure delivered via a nasal or face mask while a patient sleeps to keep the airways open.
다른 이름들:
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활성 비교기: Dental device
Participants will use a sleep dental device to treat their obstructive sleep apnea.
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An oral appliance worn during sleep to move the lower jaw forward, which tightens soft tissues and widens the airway to prevent sleep apnea.
다른 이름들:
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활성 비교기: Medications - atomoxetine-oxybutynin
Participants will use the medication combination of atomoxetine-oxybutynin to treat their obstructive sleep apnea.
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The combination of two medications (atomoxetine-oxybutynin) can reduce obstructive sleep apnea by increasing upper airway muscle activity.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health-related quality of life
기간: At 12 months
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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.
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At 12 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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OSA treatment effectiveness - Effective AHI score
기간: 12 months
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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.
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12 months
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OSA treatment effectiveness - PROMIS-Sleep Related Impairment 8a
기간: 12 months
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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.
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12 months
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Changes in systolic blood pressure
기간: 12 months
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To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving systolic blood pressure (mmHg) over 12 months.
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12 months
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Changes in diastolic blood pressure
기간: 12 months
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To compare the effectiveness of PAP therapy versus dental device versus atomoxetine-oxybutynin in improving diastolic blood pressure (mmHg) over 12 months.
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12 months
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OSA treatment adherence
기간: 12 months
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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.
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12 months
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Adverse effects of OSA treatment
기간: 12 months
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Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
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12 months
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Change From Baseline in PROMIS Sleep Disturbance v2.0 T-Score at 12 Months
기간: 12 months
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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.
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12 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Sairam Parthasarathy, MD, University of Arizona
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Platt AB, Field SH, Asch DA, Chen Z, Patel NP, Gupta R, Roche DF, Gurubhagavatula I, Christie JD, Kuna ST. Neighborhood of residence is associated with daily adherence to CPAP therapy. Sleep. 2009 Jun;32(6):799-806. doi: 10.1093/sleep/32.6.799.
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2030년 3월 1일
연구 완료 (추정된)
2032년 5월 1일
연구 등록 날짜
최초 제출
2026년 6월 4일
QC 기준을 충족하는 최초 제출
2026년 6월 29일
처음 게시됨 (실제)
2026년 7월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 29일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BPS-2024C2-37819
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
De-identified outcomes data, including a data dictionary will be made available.
IPD 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
예
미국에서 제조되어 미국에서 수출되는 제품
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Fujian Shengdi Pharmaceutical Co., Ltd.모병Bstructive sleep apnea (OSA) 및 비만중국
Positive airway pressure (PAP) therapy에 대한 임상 시험
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