Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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SP
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São Paulo, SP, Brasil, 04023-062
- Reclutamiento
- Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia
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Investigador principal:
- Lia Rita A Bittencourt, MD, PhD
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Contacto:
- Lia Rita A Bittencourt, MD,PhD
- Número de teléfono: 115521490155
- Correo electrónico: lia@psicobio.epm.br
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Contacto:
- Lia Rita A Bittencourt, MD, PhD
- Número de teléfono: 115521490155
- Correo electrónico: lia@psicobio.epm.br
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Sub-Investigador:
- Thays CA Cunha
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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:
- Male subjects aged between 25 and 65 years old
- Epworth sleepiness Scale > 9
- Apnea-hypopnea index between 5 and 30
Exclusion Criteria:
- Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
- Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
- Loss of posterior dental support to undermine the retention of oral appliance
- Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
- Protrusive displacement lass then five millimeters
- Limited mouth opening
- Alcoholism
- Use of sleep-inducing medications
- Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
- Intolerance to CPAP
- Obesity grade II (moderate) or III (severe)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective sleep parameters
Periodo de tiempo: two months after the baseline recording
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polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
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two months after the baseline recording
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Subjective sleep parameters
Periodo de tiempo: two months after the baseline recording
|
Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
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two months after the baseline recording
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Quality of life, mood, and anthropometric measurements
Periodo de tiempo: two months after the baseline recording
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SF-36, POMS, neck circumference and craniofacial characteristic
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two months after the baseline recording
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lia Rita A Bittencourt, MD, PhD, Federal University of São Paulo
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0352/09T
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