Obstructive Sleep Apnea SyndromeNCT02839499
Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food
A study testing RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- RU sleeping®, autonomy scale (ADL and AGGIR), various activity scale (IADL)
- Keywords
- seniors, mixed food, normal texture food
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RU sleeping®Device
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.
autonomy scale (ADL and AGGIR)Other
autonomy data
various activity scale (IADL)Other
activity of life data
| Study group | Role | What they receive |
|---|---|---|
| mixed food | Experimental | experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) Receives: Device: RU sleeping®; Other: autonomy scale (ADL and AGGIR); Other: various activity scale (IADL) |
| normal texture food | Other | control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) Receives: Device: RU sleeping®; Other: autonomy scale (ADL and AGGIR); Other: various activity scale (IADL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of the index of respiratory events
measured with holter (RU-sleeping®)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start15 Nov 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: physician's departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie CRAWFORD-ACHOUR, MD, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839499
- Sponsor's protocol ID
- 1608080
- Other IDs
- 2016-A01066-45
- Status last verified
- Mar 2019
- First submitted
- 8 Jul 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Obstructive Sleep Apnea Syndrome in Residents of a Unit of Long-term Care Under Mixed Food
- ClinicalTrials.gov ID
- NCT02839499
- Acronym / sponsor ID
- 1608080
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- seniors, mixed food, normal texture food
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: physician's departure
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mixed food | Experimental | Device: RU sleeping®, Other: autonomy scale (ADL and AGGIR), Other: various activity scale (IADL)experimental group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) |
| normal texture food | Other | Device: RU sleeping®, Other: autonomy scale (ADL and AGGIR), Other: various activity scale (IADL)control group with RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | mixed food, normal texture food |
| autonomy scale (ADL and AGGIR)autonomy data | Other | mixed food, normal texture food |
| various activity scale (IADL)activity of life data | Other | mixed food, normal texture food |
Primary outcome
measure of the index of respiratory events
Time frame: up to 24 hours
measured with holter (RU-sleeping®)
Results and safety
The study was stopped early (reason given: physician's departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie CRAWFORD-ACHOUR, MD principal investigator
CHU de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RU sleeping®, autonomy scale (ADL and AGGIR) and various activity scale (IADL) in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: physician's departure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of the index of respiratory events (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.