Sleep Apnea in Frail Elderly (SAFE)

This study has been completed.
Sponsor:
Information provided by:
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT01294137
First received: February 10, 2011
Last updated: May 7, 2013
Last verified: February 2011
  Purpose

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.


Condition Intervention
Ageing
Sleep Apnea
Device: ventilatory polygraphy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Enrollment: 80
Study Start Date: March 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ventilatory polygraphy Device: ventilatory polygraphy

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294137

Locations
France
CHU Grenoble
La Tronche, France, 38700
Sponsors and Collaborators
AGIR à Dom
Investigators
Principal Investigator: Sylvie Maziere, MD CHU Grenoble
Study Chair: Gaëtan Gavazzi, MD PhD CHU Grenoble
Study Chair: Catherine Bioteau, MD CHU Grenoble
Study Chair: Pascal Couturier, MD, PhD CHU Grenoble
Study Chair: Renaud Tamisier, MD CHU Grenoble
Study Chair: Sandrine Launois, MD CHU Grenoble
Study Chair: Patrick Lévy, MD, PhD CHU Grenoble
Study Director: Jean-Louis Pépin, MD, PhD CHU Grenoble
  More Information

No publications provided

Responsible Party: Dr Maziere Sylvie, CHU, Grenoble, France
ClinicalTrials.gov Identifier: NCT01294137     History of Changes
Other Study ID Numbers: 10-AGIR-3
Study First Received: February 10, 2011
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AGIR à Dom:
frail
elderly
hospitalized
sleep apnea
oximetry

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014