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

March 20, 2019 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • CHU de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mixed food
experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
Device: 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.
Other: autonomy scale (ADL and AGGIR)
autonomy data
Other: various activity scale (IADL)
activity of life data
Other: normal texture food
control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
Device: 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.
Other: autonomy scale (ADL and AGGIR)
autonomy data
Other: various activity scale (IADL)
activity of life data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure of the index of respiratory events
Time Frame: up to 24 hours
measured with holter (RU-sleeping®)
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Emilie CRAWFORD-ACHOUR, MD, CHU de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

July 8, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608080
  • 2016-A01066-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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