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Sleep Apnea in Frail Elderly (SAFE)

Primary Purpose

Ageing, Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ventilatory polygraphy

About this trial

This is an interventional diagnostic trial for Ageing focused on measuring frail, elderly, hospitalized, sleep apnea, oximetry

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Grenoble

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

ventilatory polygraphy

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01294137

First Posted

February 10, 2011

Last Updated

May 7, 2013

Sponsor

AGIR à Dom

1. Study Identification

Unique Protocol Identification Number

NCT01294137

Brief Title

Sleep Apnea in Frail Elderly

Acronym

SAFE

Official Title

Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AGIR à Dom

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ageing, Sleep Apnea

Keywords

frail, elderly, hospitalized, sleep apnea, oximetry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ventilatory polygraphy

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

ventilatory polygraphy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: