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

NCT ID: NCT02839499

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-15

Study Completion Date

2017-03-01

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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mixed food

experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)

Group Type EXPERIMENTAL

RU sleeping®

Intervention Type DEVICE

Each patient included in the study has a test by RU-sleeping. The diagnosis of obstructive sleep apnea syndrome will be asked for an index of respiratory events estimated as greater than or equal to 10.

autonomy scale (ADL and AGGIR)

Intervention Type OTHER

autonomy data

various activity scale (IADL)

Intervention Type OTHER

activity of life data

normal texture food

control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)

Group Type OTHER

RU sleeping®

Intervention Type DEVICE

Each patient included in the study has a test by RU-sleeping. The diagnosis of obstructive sleep apnea syndrome will be asked for an index of respiratory events estimated as greater than or equal to 10.

autonomy scale (ADL and AGGIR)

Intervention Type OTHER

autonomy data

various activity scale (IADL)

Intervention Type OTHER

activity of life data

Interventions

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RU sleeping®

Each patient included in the study has a test by RU-sleeping. The diagnosis of obstructive sleep apnea syndrome will be asked for an index of respiratory events estimated as greater than or equal to 10.

Intervention Type DEVICE

autonomy scale (ADL and AGGIR)

autonomy data

Intervention Type OTHER

various activity scale (IADL)

activity of life data

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilie CRAWFORD-ACHOUR, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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CHU de Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01066-45

Identifier Type: OTHER

Identifier Source: secondary_id

1608080

Identifier Type: -

Identifier Source: org_study_id

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