Study Stopped
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Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food
2 other identifiers
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedStudy Start
First participant enrolled
November 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 21, 2019
March 1, 2019
4 months
July 8, 2016
March 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measure of the index of respiratory events
measured with holter (RU-sleeping®)
up to 24 hours
Study Arms (2)
mixed food
EXPERIMENTALexperimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
normal texture food
OTHERcontrol group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Saint Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie CRAWFORD-ACHOUR, MD
CHU de Saint Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2016
First Posted
July 21, 2016
Study Start
November 15, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
March 21, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share