Glaucoma and Sleep Quality

NCT ID: NCT04703959

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-01-31

Brief 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 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.

Conditions

Glaucoma, Open-Angle

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

polysomnography

Intervention Type: OTHER

polysomnography is already done for all patients

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

polysomnography

Intervention Type: OTHER

polysomnography is already done for all patients

Interventions

polysomnography

polysomnography is already done for all patients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Adult person under tutorship or curatorship or unable to express their consent / opposition
• Person deprived of liberty
• Opposition expressed to the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2020-A01949-30

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.227

Identifier Type: -

Identifier Source: org_study_id