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NCT02839499 Clinical Trial

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

Obstructive Sleep Apnea Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02839499
Other study ID # 1608080
Secondary ID 2016-A01066-45
Status Terminated
Phase N/A
First received
Last updated
Start date November 15, 2016
Est. completion date March 1, 2017

Study information
Verified date March 2019
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 39
Est. completion date March 1, 2017
Est. primary completion date March 1, 2017
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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
• various activity scale (IADL)
activity of life data

Locations
Country Name City State
France CHU de Saint Etienne Saint Etienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary measure of the index of respiratory events measured with holter (RU-sleeping®) up to 24 hours
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