- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01294137
Sleep Apnea in Frail Elderly (SAFE)
Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Secondary goals:
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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La Tronche, France, 38700
- CHU Grenoble
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age > 75 ans
- affiliation to the French health care system
Exclusion Criteria:
- hypoxemia with oxygenotherapy
- already known and treated sleep apnea syndrome
- mild to severe dementia (MMSE<18/30)
- nocturnal neurpsychological disturbances
- acute organic failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ventilatory polygraphy
|
Collaborators and Investigators
Sponsor
Investigators
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-AGIR-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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