Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers
Sleep Apnea
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 50 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 128 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Previous studies have shown that programs encouraging the use of OSA treatments can help patients use these treatments more often, but the improvement is usually modest. This trial will test if giving patients a decision-making tool when they are first diagnosed with OSA, and combining their responses from this tool into a supportive program, will improve sleep quality and help them use their treatment more regularly.
Leer la descripción completa
Background and Significance:
Obstructive Sleep Apnea (OSA) is a significant health issue for many middle-aged and older Veterans. This condition can lead to daytime sleepiness and poor sleep quality and is a risk factor for more serious conditions such as cardiovascular disease, cognitive decline, and even increased risk of death. Common treatments for OSA include the use of medical devices such as positive airway pressure machines or oral appliances. However, many Veterans find these devices uncomfortable or difficult to use regularly. This clinical trial aims to test a new 4 session program to help Veterans stick to their OSA treatment plans using a more person-centered approach.
Innovation and Impact:
This innovative, person-centered approach is integral to the VA's "age-friendly" healthcare transformation. By focusing on what matters most to older Veterans, the investigators aim to enhance their compliance with, and the effectiveness of, OSA therapy. Aligning OSA treatment decisions with each Veteran's health priorities is expected to improve their overall wellbeing and make OSA treatments more effective.
Specific Aims:
1. Improve Sleep Quality: To determine if the new program improves patient-reported outcomes, specifically sleep quality.
2. Enhance Therapy Adherence: To evaluate if the new program increases acceptance and adherence to OSA device therapy.
3. Align Treatment with Priorities: To assess the impact of the program on ensuring that treatment decisions align with each patient's health priorities and values.
Methodology: The investigators will conduct a 5-year multi-site randomized controlled trial with a total of 128 Veterans across sites, aged 50 and older who have been newly diagnosed with OSA. Participants will be randomly assigned to either the new program or an active-control program (both programs include 1 self-directed session and 3 sessions delivered by sleep providers) that incorporate behavioral adherence strategies currently used in the investigators sleep centers. The research team will measure the outcomes 6 months after the program ends.
Path to Translation/Implementation:
The long-term goal of this work is to improve sleep quality and use of prescribed OSA therapies among middle-aged and older Veterans with OSA. If successful, the investigators will implement the intervention at the investigators' institutions and conduct a future type 2 hybrid design trial to test both the effectiveness of the program and its potential for wider implementation.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period
- currently untreated for obstructive sleep apnea (not prescribed therapy in the past year)
Exclusion Criteria:
- referral for overnight sleep test is for another reason than to diagnosis sleep-disordered breathing
- unable to read printed material (e.g., magazine) in English language
- unable to write
- unstable medical/psychiatric illness (e.g., recent hospitalization)
- Telephone Mini-Mental State Examination (MMSE) \< 21 or diagnosis of dementia
- unstable housing
- unable to attend study video or in-person visits
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Sleep education program X + Y
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.
Behavioral: Behavioral strategy program X plus Y
Sleep education program X
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
Behavioral: Behavioral strategy program X
Behavioral strategy program X plus Y BEHAVIORAL
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.
Behavioral strategy program X BEHAVIORAL
Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Pittsburgh Sleep Quality Index (PSQI)
Plazo: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
The PSQI total score will be used as a measurement of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.
Medidas secundarias
Acceptance of therapy
Plazo: One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.
Percentage of participants prescribed device therapy with \> 0 days of use in the 30 days prior to the 6-month follow-up timepoint.
Treatment adherence by machine report
Plazo: 6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.
Percentage of days of machine reported use \>= 4 hours in the prior 30 days.
Otras medidas
Decisional Conflict Scale - 1 item
Plazo: End of session 1, which is within 7 days of randomization.
Decisional Conflict Scale "What's important" item. This item is scored as 0 (best) to 4 (worst).
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
2 centros
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California, United StatesEstado desconocido
John D. Dingell VA Medical Center, Detroit, MIDetroit, Michigan, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- VA Office of Research and Development
- Inicio del estudio
- 4 ene 2027 Estimado
- Finalización primaria
- 30 sept 2030 Estimado
- Finalización del estudio
- 31 mar 2031 Estimado
- Primera publicación
- 6 oct 2025 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Helping Veterans With Obstructive Sleep Apnea Determine What Matters Most in Choosing a Treatment Option: a Randomized Trial
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026