Sleep Apnea in Frail Elderly (SAFE)

May 7, 2013 updated by: AGIR à Dom

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

Completed

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

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • CHU Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: ventilatory polygraphy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGIR à Dom

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 10, 2011

First Posted (Estimate)

February 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

February 1, 2011

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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