Sleep Apnea in Frail Elderly (SAFE)
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline).
Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients|
|Study Start Date:||March 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: ventilatory polygraphy||Device: ventilatory polygraphy|
Main goal: to define the more specific and sensitive cut-off of variability index of the oximetry to detect sleep apnea in the hospitalized elderly.
- sleep apnea prevalence in the elderly
- accuracy of other oximetry parameters (saturation line, oximetry desaturation index, autonomic arousals) for detection of respiratory disturbances in sleep apnea in the hospitalized elderly
- to determine the clinical and biological data associated with sleep apnea in the hospitalized elderly
- to determine the factors associated with the record failures and its prevalence
- to study the prevalence of the Periodic Limb Movements of Sleep in the hospitalized elderly
Study design: simultaneous records by oximetry and ventilatory polygraphy with tibial EMG in the hospitalized elderly in a geriatric readaptation unit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01294137
|La Tronche, France, 38700|
|Principal Investigator:||Sylvie Maziere, MD||CHU Grenoble|
|Study Chair:||Gaëtan Gavazzi, MD PhD||CHU Grenoble|
|Study Chair:||Catherine Bioteau, MD||CHU Grenoble|
|Study Chair:||Pascal Couturier, MD, PhD||CHU Grenoble|
|Study Chair:||Renaud Tamisier, MD||CHU Grenoble|
|Study Chair:||Sandrine Launois, MD||CHU Grenoble|
|Study Chair:||Patrick Lévy, MD, PhD||CHU Grenoble|
|Study Director:||Jean-Louis Pépin, MD, PhD||CHU Grenoble|