Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT04703959
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.
Study:
NCT04703959
Study Brief:
Protocol Section:
NCT04703959