Vigilance DysfunctionVISANCT03344263
Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
A study testing tests of attentional performance in people with Vigilance Dysfunction, run by Poitiers University Hospital at 1 site in France.
Trial summary
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP). Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Vigilance Dysfunction
- What is being tested?
- tests of attentional performance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2017to 9 Feb 2021
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20-70 years
- Memory disorders without memory problems in episodic memory
- Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure
- Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10)
- Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h)
Who cannot join
- Age <20 years or ≥ 70 years
- Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
- Dysthyroidism
- Severe depression, schizophrenia, bipolar disorder
- Treatment with an effect on cognition: hypnotics, sedative
- Chronic Obstructive Pulmonary Disease
Show all 9Show fewer
- Chronic alcoholism, other addictions
- Contraindications to Magnetic Resonance Imaging
- Refusal of equipment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).
All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.
The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.
- Conditions
- Vigilance Dysfunction
- Being tested
- tests of attentional performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tests of attentional performanceDiagnostic test
tests of attentional performance before and after 6 months of continuous positive airways pressure
| Study group | Role | What they receive |
|---|---|---|
| tests of attentional performance | Experimental | Not described Receives: Diagnostic Test: tests of attentional performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP
Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP
Measured: After 6 months of continuous positive airways pressure in the OSAHS patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Nov 2017
- Primary completion9 Feb 2021
- Study completion9 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vigilance DysfunctionStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344263
- Sponsor's protocol ID
- VISA
- Acronym
- VISA
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2017
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep
- ClinicalTrials.gov ID
- NCT03344263
- Acronym / sponsor ID
- VISA / VISA
- Conditions
- Vigilance Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 9 Feb 2021 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).
All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.
The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tests of attentional performance | Experimental | Diagnostic Test: tests of attentional performance |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 20-70 years
- Memory disorders without memory problems in episodic memory
- Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure
Key exclusion criteria (9 listed)
- Age <20 years or ≥ 70 years
- Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
- Dysthyroidism
- Severe depression, schizophrenia, bipolar disorder
- Treatment with an effect on cognition: hypnotics, sedative
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 |
|---|---|---|
| tests of attentional performancetests of attentional performance before and after 6 months of continuous positive airways pressure | Diagnostic test | tests of attentional performance |
Primary outcome
Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP
Time frame: After 6 months of continuous positive airways pressure in the OSAHS patient
Reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP
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 29 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tests of attentional performance in people with Vigilance Dysfunction, run by Poitiers University Hospital 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 5 inclusion and 9 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 29 Nov 2021. 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.
What does the primary outcome measure?
Study of the reversibility of vigilance disorders on the number of omissions in the subtest visual vigilance of the TAP (time frame: After 6 months of continuous positive airways pressure in the OSAHS patient). 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 29 Nov 2021.