Glaucoma and Sleep Quality

NCT04703959 | Unknown

• 2 other identifiers: 38RC20.2272020-A01949-30
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

• To study the polysomnographic characteristics of sleep in glaucomatous and non-glaucomatous subjects

  Total sleep time in glaucomatous and control subjects

  Baseline (PSG)

Secondary Outcomes (1)

• To characterize of the architecture of sleep in glaucomatous and non-glaucomatous subjects.

  Baseline (PSG)

Study Arms (2)

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

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

Other: polysomnography

Interventions

polysomnography OTHER

polysomnography is already done for all patients

glaucomatous subjects (50); non glaucomatous subjects (100)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 11, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 11, 2021

Record last verified: 2021-01