Glaucoma, Open-AnglePOLY-GLAUCOMANCT04703959
Glaucoma and Sleep Quality
An observational study of Glaucoma, Open-Angle, run by University Hospital, Grenoble.
Trial summary
This study is a observational, prospective, case-control, monocentric study. The main objective is to study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects, using data collected in the MARS database of CHU Grenoble-Alpes, to compare the total sleep time of glaucomatous and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- polysomnography
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our population is taken from the MARS database. The MARS database (Multimorbidity Apnea Respiratory failure Sleep database) is a database designed by the EFCR CHU Grenoble Alpes laboratory. It consists of patients with respiratory pathology associated or not with other pathologies and patients with respiratory pathology associated with several co-morbidities. It is a database that has so far received all the legal authorizations required for its use and scientific exploitation (CCTIRS: Request for advice N ° 15.925bis, favorable opinion obtained on 03/23/2016; CNIL: Declaration of conformity to the reference methodology MR003 N ° 1996650v0 on 05/10/2016). This database is also managed in compliance with GDPR rules.
Who may be able to join
- Subjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics:
- Glaucoma group: increase in intraocular pressure (IOP before treatment greater than 21 mmHg) with characteristic alterations of the optic nerve (pathological papillary excavation, papillary pallor, papillary atrophy) with corresponding alterations and characteristics of the visual field. The visual field should be considered reliable (European criteria (European Glaucoma Society, 1999).
- Control group: no known ophthalmological pathologies, with an ophthalmological examination on telephone examination - in the 2 years preceding the polysomnographic examination - normal apart from minor refractive disorders (myopia with spherical equivalent less than -6 diopters or hyperopia with spherical equivalent less than 3 diopters).
- Patients whose age is greater than or equal to 18 years
- Male or female patients
- Non-opposition to the study
- Affiliation to a social security scheme or beneficiary of such a scheme
Who cannot join
- Adult person under tutorship or curatorship or unable to express their consent / opposition
- Person deprived of liberty
- Opposition expressed to the study
About this study
This study is a observational, prospective, case-control, monocentric study.
The main objective is to study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects, using data collected in the MARS database of CHU Grenoble-Alpes, to compare the total sleep time of glaucomatous and non-glaucomatous subjects, measured during the polysomnographic examination collected in the database.
Read more
The secondary objectives are the exhaustive characterization of the sleep architecture in glaucomatous and non-glaucomatous subjects, from data collected in the MARS database of the CHU Grenoble-Alpes
- Length of sleep period
- Time spent in phase 1, 2, 3 and 4
- Micro-alarm clocks index
- Time with arterial oxygen saturation less than 90%
- Apnea-hypopnea index
Read the detailed description
Glaucoma is an eye and neurodegenerative disease characterized by progressive destruction of optic nerve cells (retinal ganglion cells), affecting vision but also the retino-hypothalamic pathway leading to the suprachiasmatic nuclei and helping to synchronize nycthemeral rhythms.
It can therefore be suggested that glaucoma may affect the structure and quality of sleep. Few studies on the subjects of sleep quality and architecture have been performed to date, and all are either small series of cases without a comparator group, or studies based on questionnaires but without polysomnographic examination. The results of studies carried out to date are conflicting.
The subject is important because glaucoma is a frequent disease (1 to 1.2 million subjects in France and 75 to 90 million in the world), and could potentially be a frequent cause of disturbance of the quality of sleep.
The CHU Grenoble-Alpes has a large database (MARS Cohort) including polysomnographic examinations of glaucomatous and non-glaucomatous subjects. The objective of this study is to characterize the sleep parameters (sleep time, sleep period, sleep stages, sleep efficiency, cycles per night, micro-arousal index, etc.) in glaucomatous and non-glaucomatous subjects, by controlling any possible confounding factors that can affect the quality of sleep (age, biometric data, associated pathologies).
This study will require confirming the diagnosis of glaucoma in subjects declared as such, and specifying the stage of glaucomatous involvement. A current ophthalmologic examination of glaucoma assessment will therefore be offered to this group of subjects (including examination of the visual field and tomography of the optic nerve). This study will also require verifying with certainty the absence of glaucoma in subjects in the control group. To this end, a telephone questionnaire will be administered to the subjects of this group.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- polysomnography
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyOther
polysomnography is already done for all patients
| Study group | Role | What they receive |
|---|---|---|
| glaucomatous subjects (50) | Subjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics:
* increase in intraocular pressure (IOP before treatment greater than 21 mmHg) with characteristic alterations of the optic nerve (pathological papillary excavation, papillary pallor, papillary atrophy) with corresponding alterations and characteristics of the visual field. The visual field should be considered reliable (European criteria (European Glaucoma Society, 1999).
* Patients whose age is greater than or equal to 18 years
* Male or female patients
* Patients not objecting to the study
* Affiliation to a social security scheme or beneficiary of such a scheme Receives: Other: polysomnography | |
| non glaucomatous subjects (100) | Subjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics:
* no known ophthalmological pathologies, with an ophthalmological examination on telephone examination - in the 2 years preceding the polysomnographic examination - normal apart from minor refractive disorders (myopia with spherical equivalent less than -6 diopters or hyperopia with spherical equivalent less than 3 diopters).
* Patients whose age is greater than or equal to 18 years
* Male or female patients
* Patients not objecting to the study
* Affiliation to a social security scheme or beneficiary of such a scheme Receives: Other: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects
Total sleep time in glaucomatous and control subjects
Measured: Baseline (PSG)
Secondary outcomes (1)
To characterize of the architecture of sleep in glaucomatous and non-glaucomatous subjects.
Length of sleep period Time spent in phase 1, 2, 3 and 4 Micro-alarm clocks index Time with saturation less than 90% Apnea-hypopnea index
Measured: Baseline (PSG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703959
- Sponsor's protocol ID
- 38RC20.227
- Other IDs
- 2020-A01949-30
- Acronym
- POLY-GLAUCOMA
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glaucoma and Sleep Quality
- ClinicalTrials.gov ID
- NCT04703959
- Acronym / sponsor ID
- POLY-GLAUCOMA / 38RC20.227
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 11 Jan 2021 (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.
This study is a observational, prospective, case-control, monocentric study.
The main objective is to study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects, using data collected in the MARS database of CHU Grenoble-Alpes, to compare the total sleep time of glaucomatous and non-glaucomatous subjects, measured during the polysomnographic examination collected in the database.
The secondary objectives are the exhaustive characterization of the sleep architecture in glaucomatous and non-glaucomatous subjects, from data collected in the MARS database of the CHU Grenoble-Alpes
- Length of sleep period
- Time spent in phase 1, 2, 3 and 4
- Micro-alarm clocks index
- Time with arterial oxygen saturation less than 90%
- Apnea-hypopnea index
Detailed description
Glaucoma is an eye and neurodegenerative disease characterized by progressive destruction of optic nerve cells (retinal ganglion cells), affecting vision but also the retino-hypothalamic pathway leading to the suprachiasmatic nuclei and helping to synchronize nycthemeral rhythms.
It can therefore be suggested that glaucoma may affect the structure and quality of sleep. Few studies on the subjects of sleep quality and architecture have been performed to date, and all are either small series of cases without a comparator group, or studies based on questionnaires but without polysomnographic examination. The results of studies carried out to date are conflicting.
The subject is important because glaucoma is a frequent disease (1 to 1.2 million subjects in France and 75 to 90 million in the world), and could potentially be a frequent cause of disturbance of the quality of sleep.
The CHU Grenoble-Alpes has a large database (MARS Cohort) including polysomnographic examinations of glaucomatous and non-glaucomatous subjects. The objective of this study is to characterize the sleep parameters (sleep time, sleep period, sleep stages, sleep efficiency, cycles per night, micro-arousal index, etc.) in glaucomatous and non-glaucomatous subjects, by controlling any possible confounding factors that can affect the quality of sleep (age, biometric data, associated pathologies).
This study will require confirming the diagnosis of glaucoma in subjects declared as such, and specifying the stage of glaucomatous involvement. A current ophthalmologic examination of glaucoma assessment will therefore be offered to this group of subjects (including examination of the visual field and tomography of the optic nerve). This study will also require verifying with certainty the absence of glaucoma in subjects in the control group. To this end, a telephone questionnaire will be administered to the subjects of this group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glaucomatous subjects (50) | – | Other: polysomnographySubjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics: * increase in intraocular pressure (IOP before treatment greater than 21 mmHg) with characteristic alterations of the optic nerve (pathological papillary excavation, papillary pallor, papillary atrophy) with corresponding alterations and characteristics of the visual field. The visual field should be considered reliable (European criteria (European Glaucoma Society, 1999). * Patients whose age is greater than or equal to 18 years * Male or female patients * Patients not objecting to the study * Affiliation to a social security scheme or beneficiary of such a scheme |
| non glaucomatous subjects (100) | – | Other: polysomnographySubjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics: * no known ophthalmological pathologies, with an ophthalmological examination on telephone examination - in the 2 years preceding the polysomnographic examination - normal apart from minor refractive disorders (myopia with spherical equivalent less than -6 diopters or hyperopia with spherical equivalent less than 3 diopters). * Patients whose age is greater than or equal to 18 years * Male or female patients * Patients not objecting to the study * Affiliation to a social security scheme or beneficiary of such a scheme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our population is taken from the MARS database. The MARS database (Multimorbidity Apnea Respiratory failure Sleep database) is a database designed by the EFCR CHU Grenoble Alpes laboratory. It consists of patients with respiratory pathology associated or not with other pathologies and patients with respiratory pathology associated with several co-morbidities. It is a database that has so far received all the legal authorizations required for its use and scientific exploitation (CCTIRS: Request for advice N ° 15.925bis, favorable opinion obtained on 03/23/2016; CNIL: Declaration of conformity to the reference methodology MR003 N ° 1996650v0 on 05/10/2016). This database is also managed in compliance with GDPR rules.
Key inclusion criteria (7 listed)
- Subjects included in the MARS database of CHU Grenoble-Alpes with available polysomnographic data and with the following ophthalmological characteristics:
- Glaucoma group: increase in intraocular pressure (IOP before treatment greater than 21 mmHg) with characteristic alterations of the optic nerve (pathological papillary excavation, papillary pallor, papillary atrophy) with corresponding alterations and characteristics of the visual field. The visual field should be considered reliable (European criteria (European Glaucoma Society, 1999).
- Control group: no known ophthalmological pathologies, with an ophthalmological examination on telephone examination - in the 2 years preceding the polysomnographic examination - normal apart from minor refractive disorders (myopia with spherical equivalent less than -6 diopters or hyperopia with spherical equivalent less than 3 diopters).
- Patients whose age is greater than or equal to 18 years
- Male or female patients
Key exclusion criteria (3 listed)
- Adult person under tutorship or curatorship or unable to express their consent / opposition
- Person deprived of liberty
- Opposition expressed to the study
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 |
|---|---|---|
| polysomnographypolysomnography is already done for all patients | Other | glaucomatous subjects (50), non glaucomatous subjects (100) |
Primary outcome
To study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects
Time frame: Baseline (PSG)
Total sleep time in glaucomatous and control subjects
1 secondary outcome
To characterize of the architecture of sleep in glaucomatous and non-glaucomatous subjects.
Time frame: Baseline (PSG)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle, run by University Hospital, Grenoble.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
To study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects (time frame: Baseline (PSG)). 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 11 Jan 2021.