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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

RU sleeping®

autonomy scale (ADL and AGGIR)

various activity scale (IADL)

About this trial

This is an interventional other trial for Obstructive Sleep Apnea Syndrome focused on measuring seniors, mixed food, normal texture food

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU de Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

mixed food

normal texture food

Arm Description

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

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

Outcomes

Primary Outcome Measures

measure of the index of respiratory events

measured with holter (RU-sleeping®)

Secondary Outcome Measures

Full Information

NCT ID

NCT02839499

First Posted

July 8, 2016

Last Updated

March 20, 2019

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT02839499

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Why Stopped

physician's departure

Study Start Date

November 15, 2016 (Actual)

Primary Completion Date

March 1, 2017 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

seniors, mixed food, normal texture food

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mixed food

Arm Type

Experimental

Arm Description

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

Arm Title

normal texture food

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

RU sleeping®

Intervention Description

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

Other

Intervention Name(s)

autonomy scale (ADL and AGGIR)

Intervention Description

autonomy data

Intervention Type

Other

Intervention Name(s)

various activity scale (IADL)

Intervention Description

activity of life data

Primary Outcome Measure Information:

Title

measure of the index of respiratory events

Description

measured with holter (RU-sleeping®)

Time Frame

up to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emilie CRAWFORD-ACHOUR, MD

Organizational Affiliation

CHU de Saint Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU de Saint Etienne

City

Saint Etienne

ZIP/Postal Code

42055

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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