Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food

Not Applicable

Terminated

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: RU sleeping®; Other: autonomy scale (ADL and AGGIR); Other: various activity scale (IADL)

• Registration Number: NCT02839499
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Obstructive sleep apnea is a condition that affects 40% to 62% of the population aged over 60 years with major consequences especially on the cardiovascular system.

This syndrome consists of a staff of the pharyngeal muscles. These muscles are also involved in swallowing phenomena and chews, or many elderly patients are subjected to a mixed diet, logically leading to atrophy of the muscles aerodigestive crossroads.

Muscle wasting ENT induced a mixed food could promote collapsibility of VAS, exposing the individual to a higher risk of apnea and hypopnea during sleep.

The objective of this study is to determine if there is a significant increase in the prevalence of obstructive sleep apnea syndrome in the elderly patients residing in long term care units, receiving a mixed food compared to residents in supply to normal texture.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Study Start: 2016-11-15
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Resident of a unit of long-term care
• Recipient or affiliated with Social Security
• Signature of consent by the patient, guardian or person of trust

and mixed food or normal texture food

Exclusion Criteria

• OSA diagnosed and treated earlier
• Patients with an abnormal upper airway out edentation
• Patients unable to give informed consent and having no confidence in individual capacity to do so.
• Patients with a gastrostomy or jejunostomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mixed food	autonomy scale (ADL and AGGIR)	experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
mixed food	various activity scale (IADL)	experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
normal texture food	autonomy scale (ADL and AGGIR)	control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
mixed food	RU sleeping®	experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
normal texture food	various activity scale (IADL)	control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
normal texture food	RU sleeping®	control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)

Primary Outcome Measures

Name	Time	Method
measure of the index of respiratory events	up to 24 hours	measured with holter (RU-sleeping®)

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint Etienne, France