Sleep Apnea in Frail Elderly

NCT ID: NCT01294137

Last Updated: 2013-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ageing Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ventilatory polygraphy

Group Type ACTIVE_COMPARATOR

ventilatory polygraphy

Intervention Type DEVICE

Interventions

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ventilatory polygraphy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AGIR à Dom

OTHER

Sponsor Role lead

Responsible Party

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CHU, Grenoble, France

Principal Investigators

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Sylvie Maziere, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Gaëtan Gavazzi, MD PhD

Role: STUDY_CHAIR

University Hospital, Grenoble

Catherine Bioteau, MD

Role: STUDY_CHAIR

University Hospital, Grenoble

Pascal Couturier, MD, PhD

Role: STUDY_CHAIR

University Hospital, Grenoble

Renaud Tamisier, MD

Role: STUDY_CHAIR

University Hospital, Grenoble

Sandrine Launois, MD

Role: STUDY_CHAIR

University Hospital, Grenoble

Patrick Lévy, MD, PhD

Role: STUDY_CHAIR

University Hospital, Grenoble

Jean-Louis Pépin, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Grenoble

Locations

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CHU Grenoble

La Tronche, , France

Site Status

Countries

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France

Other Identifiers

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10-AGIR-3

Identifier Type: -

Identifier Source: org_study_id

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