Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea
Palabras clave
Abstracto
fechas
Verificado por última vez: | 02/29/2020 |
Primero enviado: | 01/21/2019 |
Inscripción estimada enviada: | 01/24/2019 |
Publicado por primera vez: | 01/27/2019 |
Última actualización enviada: | 03/02/2020 |
Última actualización publicada: | 03/03/2020 |
Fecha de inicio real del estudio: | 01/31/2019 |
Fecha estimada de finalización primaria: | 12/31/2021 |
Fecha estimada de finalización del estudio: | 12/31/2021 |
Condición o enfermedad
Intervención / tratamiento
Diagnostic Test: Suspected OSA
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Suspected OSA | Diagnostic Test: Suspected OSA Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich |
Criterio de elegibilidad
Edades elegibles para estudiar | 18 Years A 18 Years |
Sexos elegibles para estudiar | All |
Método de muestreo | Non-Probability Sample |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Informed consent - Suspected obstructive sleep apnea - ≥18 years old Exclusion Criteria: - Suspected or diagnosed sleeping-disordered breathing other than OSA - Moribund or severe disease prohibiting protocol adherence especially COPD GOLD III-IV and heart failure NYHA III-IV - Patients receiving oxygen therapy or home ventilation - Continuous positive airway pressure treatment for OSA at baseline - Physical or intellectual impairment precluding informed consent or protocol adherence - Pregnant patients |
Salir
Medidas de resultado primarias
1. The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights [14 nights of pulse-oximetry]
2. Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring [14 nights of pulse-oximetry]
Medidas de resultado secundarias
1. ODI variability measured in 14 consecutive nights of pulse-oximetry [14 nights of pulse-oximetry]
2. Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability [14 nights of pulse-oximetry]
3. Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry [14 nights of pulse-oximetry]
4. Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring [14 nights of pulse-oximetry]
5. Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA [14 nights of pulse-oximetry]