Sleep Apnea in Frail Elderly | NCT01294137

Studies
Sleep Apnea in Frail Elderly

NCT01294137

Sponsor

AGIR à Dom

Status

Completed

Last Update Posted

May 9, 2013Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Ageing
Sleep Apnea

Interventions

ventilatory polygraphy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Feb 10, 2011

First Submission Date that Met QC Criteria

Feb 10, 2011

First Posted Date

Feb 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2013

Last Update Posted Date

May 9, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AGIR à DomOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ventilatory polygraphy	Active Comparator		Device: ventilatory polygraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ventilatory polygraphy	Device		ventilatory polygraphy

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Grenoble		La Tronche		38700	France

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided