AgeingSAFENCT01294137
Sleep Apnea in Frail Elderly
A study testing ventilatory polygraphy in people with Ageing and Sleep Apnea, run by AGIR à Dom at 1 site in France.
Trial summary
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline). Today, there is no specific tool to detect sleep apnea in the elderly. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Ageing, Sleep Apnea
- What is being tested?
- ventilatory polygraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2013
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 75 ans
- affiliation to the French health care system
Who cannot join
- hypoxemia with oxygenotherapy
- already known and treated sleep apnea syndrome
- mild to severe dementia (MMSE<18/30)
- nocturnal neurpsychological disturbances
- acute organic failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline).
Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.
Read the detailed description
Main goal: to define the more specific and sensitive cut-off of variability index of the oximetry to detect sleep apnea in the hospitalized elderly.
Secondary goals:
- sleep apnea prevalence in the elderly
- accuracy of other oximetry parameters (saturation line, oximetry desaturation index, autonomic arousals) for detection of respiratory disturbances in sleep apnea in the hospitalized elderly
- to determine the clinical and biological data associated with sleep apnea in the hospitalized elderly
- to determine the factors associated with the record failures and its prevalence
- to study the prevalence of the Periodic Limb Movements of Sleep in the hospitalized elderly
Study design: simultaneous records by oximetry and ventilatory polygraphy with tibial EMG in the hospitalized elderly in a geriatric readaptation unit.
- Conditions
- Ageing, Sleep Apnea
- Being tested
- ventilatory polygraphy
- Keywords
- frail, elderly, hospitalized, sleep apnea, oximetry
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilatory polygraphyDevice
| Study group | Role | What they receive |
|---|---|---|
| ventilatory polygraphy | Active comparator | Not described Receives: Device: ventilatory polygraphy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Investigators
- Sylvie Maziere, MD, Principal investigator, University Hospital, GrenobleGaëtan Gavazzi, MD PhD, Study chair, University Hospital, GrenobleCatherine Bioteau, MD, Study chair, University Hospital, GrenoblePascal Couturier, MD, PhD, Study chair, University Hospital, GrenobleRenaud Tamisier, MD, Study chair, University Hospital, GrenobleSandrine Launois, MD, Study chair, University Hospital, GrenoblePatrick Lévy, MD, PhD, Study chair, University Hospital, GrenobleJean-Louis Pépin, MD, PhD, Study director, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294137
- Sponsor's protocol ID
- 10-AGIR-3
- Acronym
- SAFE
- Status last verified
- Feb 2011
- First submitted
- 10 Feb 2011
- Last updated
- 9 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Pulse Oximetry to Detect Sleep Apnea in Frail Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01294137
- Acronym / sponsor ID
- SAFE / 10-AGIR-3
- Conditions
- Ageing, Sleep Apnea
- Keywords
- frail, elderly, hospitalized, sleep apnea, oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Feb 2011 (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.
Sleep apnea syndrome is common and increases with age. In the elderly, symptoms might be different than in the youngest people, and its consequences might be severe and atypical (falls, functional and cognitive decline).
Today, there is no specific tool to detect sleep apnea in the elderly. The goal of this study is to evaluate the accuracy of oximetry for detection of respiratory disturbances in sleep apnea in the hospitalized elderly.
Detailed description
Main goal: to define the more specific and sensitive cut-off of variability index of the oximetry to detect sleep apnea in the hospitalized elderly.
Secondary goals:
- sleep apnea prevalence in the elderly
- accuracy of other oximetry parameters (saturation line, oximetry desaturation index, autonomic arousals) for detection of respiratory disturbances in sleep apnea in the hospitalized elderly
- to determine the clinical and biological data associated with sleep apnea in the hospitalized elderly
- to determine the factors associated with the record failures and its prevalence
- to study the prevalence of the Periodic Limb Movements of Sleep in the hospitalized elderly
Study design: simultaneous records by oximetry and ventilatory polygraphy with tibial EMG in the hospitalized elderly in a geriatric readaptation unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilatory polygraphy | Active comparator | Device: ventilatory polygraphy |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- age > 75 ans
- affiliation to the French health care system
Key exclusion criteria (5 listed)
- hypoxemia with oxygenotherapy
- already known and treated sleep apnea syndrome
- mild to severe dementia (MMSE<18/30)
- nocturnal neurpsychological disturbances
- acute organic failure
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 |
|---|---|---|
| ventilatory polygraphy | Device | ventilatory polygraphy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2013.
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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.
Sylvie Maziere, MD principal investigator
University Hospital, Grenoble
Gaëtan Gavazzi, MD PhD study chair
University Hospital, Grenoble
Catherine Bioteau, MD study chair
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilatory polygraphy in people with Ageing and Sleep Apnea, run by AGIR à Dom 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 May 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 9 May 2013; AzTrials last refreshed its copy on 31 Oct 2026.