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Clinical Trials/NCT02839499
NCT02839499TerminatedNot Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country39 target enrollmentStarted: November 15, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
39
Locations
1
Primary Endpoint
measure of the index of respiratory events

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

normal texture food

Other

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

Intervention: various activity scale (IADL) (Other)

normal texture food

Other

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

Intervention: RU sleeping® (Device)

normal texture food

Other

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

Intervention: autonomy scale (ADL and AGGIR) (Other)

mixed food

Experimental

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

Intervention: RU sleeping® (Device)

mixed food

Experimental

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

Intervention: autonomy scale (ADL and AGGIR) (Other)

mixed food

Experimental

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

Intervention: various activity scale (IADL) (Other)

Outcomes

Primary Outcomes

measure of the index of respiratory events

Time Frame: up to 24 hours

measured with holter (RU-sleeping®)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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