- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00310310
Effect of Self-Management on Improving Sleep Apnea Outcomes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92161
- VA San Diego Healthcare System
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of obstructive sleep apnea
- No previous use of CPAP
- Must be a Veteran with residence within San Diego County
Exclusion Criteria:
- Home oxygen therapy
- Fatal comorbidities (i.e., life expectancy less than 6 mos)
- Contraindications for CPAP use
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador de placebos: Usual Care
Usual sleep apnea and cpap care
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Usual sleep apnea and cpap care
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Experimental: Self-Management
sleep apnea self-management program - 4 sessions, group-based
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Sleep apnea self-management program - 4 sessions, group-based.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
CPAP Adherence
Periodo de tiempo: 1 month
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The investigators examined the data obtained in the Sleep Apnea Self-Management Program at the one-month time point relative to participation in the Usual Care group.
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1 month
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CPAP Adherence
Periodo de tiempo: 6 months
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The investigators also examined the data obtained at the 6-month time point.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 1 Month
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
1 Month
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 6 Months
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire aimed at assessing sleep quality and disturbances over a 1-month period.79 The PSQI measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Items are answered utilizing a Likert scale with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. The PSQI has acceptable reliability (Cronbach's alpha = 0.83), test-retest reliability of 0.85, and can distinguish good and poor sleepers (global PSQI score > 5 has diagnostic sensitivity = 89.6% and specificity 86.5%). In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
6 Months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sleep Apnea Quality of Life Index (SAQLI)
Periodo de tiempo: 1 month
|
Sleep Apnea Quality of Life Index (SAQLI) which is a 35-item clinician-administered scale composed of five domains: daily functioning, social interactions, emotional functioning, symptoms, and CPAP side effects. . It has high internal consistency, strong content and construct validity, and adequate concurrent and discriminative validity, and is responsive to changes in HRQOL. The key advantages to inclusion of the SAQLI is that it is the only clinician-administered scale in the study and it contains a CPAP side effect scale that is one of the few valid measures of the frequency and amount of CPAP side effects.
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1 month
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Quality of Well Being Scale (QWB-SA)
Periodo de tiempo: 1 month
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The QWB-SA is a generic, preference-based measure that produces a single score appropriate for cost-effectiveness estimates and has been used in veteran and other general adult populations.
The advantage of having a single, scaled score instead of multiple separate subscale domains is important for comparing interventions.
The QWB-SA is a comprehensive measure of health-related quality of life that consists of 78-items and five sections: (I) acute and chronic symptoms; (II) self-care activities; (III) mobility; (IV) physical activity and performance of physical functioning; and (V) social activity.
The level of functioning and the subjective symptom reports are then weighted by preference, or utility, on a scale that ranges from 0 (dead) to 1.0 (optimum function).
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1 month
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Self-Efficacy
Periodo de tiempo: 1 month
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Social-cognitive theory (SCT) measure 1= Disagree Completely 5= Agree Completely 6= Not applicable |
1 month
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Outcome Expectation
Periodo de tiempo: 1 month
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Social-cognitive theory (SCT) measure 1= Not at all important 5= Extremely important 6= Not applicable |
1 month
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Center for Epidemiological Studies - Depression Scale (Short Form)
Periodo de tiempo: 1 month
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The CES-D is a 10-item self-report measure of depression. The 10-item version has adequate predictive accuracy when compared to the original full-length 20-item version, as well as adequate test-retest correlations and discriminative validity. The total score is calculated by finding the sum of 10 items. Any score equal to or above 10 is considered depressed. |
1 month
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Epworth Sleepiness Scale (ESS)
Periodo de tiempo: 1 month
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ESS is a widely used subjective measure of excessive daytime sleepiness in research and clinical settings.
Participants are asked to indicate how likely they would be to fall asleep in eight different situations on a scale from 0 (not likely) to 3 (highly likely).
The situations are designed to vary in sleep-inducing capacity.
The ESS scoring range is 0-24, with higher scores reflecting greater daytime sleepiness.
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1 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carl J Stepnowsky, PhD, San Diego Veterans Healthcare System
Publicaciones y enlaces útiles
Publicaciones Generales
- Stepnowsky CJ, Palau JJ, Gifford AL, Ancoli-Israel S. A self-management approach to improving continuous positive airway pressure adherence and outcomes. Behav Sleep Med. 2007;5(2):131-46. doi: 10.1080/15402000701190622.
- Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
- Stepnowsky CJ, Ancoli-Israel S. Sleep and Its Disorders in Seniors. Sleep Med Clin. 2008;3(2):281-293. doi: 10.1016/j.jsmc.2008.01.011. No abstract available.
- Deering S, Liu L, Zamora T, Hamilton J, Stepnowsky C. CPAP Adherence is Associated With Attentional Improvements in a Group of Primarily Male Patients With Moderate to Severe OSA. J Clin Sleep Med. 2017 Dec 15;13(12):1423-1428. doi: 10.5664/jcsm.6838.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IIR 02-275
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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