Sleep Apnea in Frail Elderly (SAFE)

AGIR à Dom

Status: Completed

Conditions: Ageing; Sleep Apnea

Treatments: Device: ventilatory polygraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT01294137

10-AGIR-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 75+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

ventilatory polygraphy

Active Comparator group

Treatment:

Device: ventilatory polygraphy