Sleep Apnea in Frail Elderly (SAFE)
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|ClinicalTrials.gov Identifier: NCT01294137|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : May 9, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Ageing Sleep Apnea||Device: ventilatory polygraphy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|Active Comparator: ventilatory polygraphy||Device: ventilatory polygraphy|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294137
|La Tronche, France, 38700|
|Principal Investigator:||Sylvie Maziere, MD||University Hospital, Grenoble|
|Study Chair:||Gaëtan Gavazzi, MD PhD||University Hospital, Grenoble|
|Study Chair:||Catherine Bioteau, MD||University Hospital, Grenoble|
|Study Chair:||Pascal Couturier, MD, PhD||University Hospital, Grenoble|
|Study Chair:||Renaud Tamisier, MD||University Hospital, Grenoble|
|Study Chair:||Sandrine Launois, MD||University Hospital, Grenoble|
|Study Chair:||Patrick Lévy, MD, PhD||University Hospital, Grenoble|
|Study Director:||Jean-Louis Pépin, MD, PhD||University Hospital, Grenoble|