Sleep Apnea in Frail Elderly

Sleep Apnea Clinical Trial

— SAFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294137
• Other study ID #: 10-AGIR-3
• Status: Completed
• Phase: N/A
• First received: February 10, 2011
• Last updated: May 7, 2013
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2011
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ageing
• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• ventilatory polygraphy

Locations

Country	Name	City	State
France	CHU Grenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Country where clinical trial is conducted

France,