NCT01294137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 9, 2013

Status Verified

February 1, 2011

Enrollment Period

2 years

First QC Date

February 10, 2011

Last Update Submit

May 7, 2013

Conditions

AgeingSleep Apnea

Keywords

frailelderlyhospitalizedsleep apneaoximetry

Study Arms (1)

ventilatory polygraphy

ACTIVE COMPARATOR
Device: ventilatory polygraphy

Interventions

ventilatory polygraphyDEVICE
ventilatory polygraphy

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age \> 75 ans
  • affiliation to the French health care system

You may not qualify if:

  • hypoxemia with oxygenotherapy
  • already known and treated sleep apnea syndrome
  • mild to severe dementia (MMSE\<18/30)
  • nocturnal neurpsychological disturbances
  • acute organic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble

La Tronche, 38700, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sylvie Maziere, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

  • Jean-Louis Pépin, MD, PhD

    University Hospital, Grenoble

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 9, 2013

Record last verified: 2011-02

Locations

FR(1)