To evaluate the sleep quality in patients with Retinitis Pigmentosa
Conditions
Interventions
Trade Name: CIRCADIN 2 mg comprimidos de liberación prolongada
Product Name: Circadin 2 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Not answered
CAS Number: 73-31-4
Current S
Sponsors
Isabel Pinilla Lozano
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a)Patients from de Ophthalmology Department b)Being 18 years old or older c)Diagnosed with Retinitis Pigmentosa d)Visual acuity equal or less than 20/200 e) In case of any other pathologies, treated with the standard treatment following the international directions and the protocols established by the Ophthalmic Unit f)Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) No informed consent b) Absence of other ophthalmological treatments if needed c) Patients affected by atypical forms of Retinitis Pigmentosa as sector or paravenous forms, Bardet Biedl or Refsum syndromes, or Retinitis punctata albescens. d) Patients with other systemic pathologies or deafness (excluding Usher syndrome) e) Pregnancy (or a likelihood of becoming pregnant) or lactation. f) Patients with other retinal diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the therapeutic effect of melatonin, orally administered, on visual and sleep disturbances in adults patients affected by Retinitis Pigmentosa.;Secondary Objective: To evaluate the protective effect of melatonin, orally administered, in patients with Retinitis Pigmentosa, measuring the following parameters: 1.Sleep quality assesses by means of Sleep Quality questionnaires 2.Rest-activity cycles monitored by actigraph recording. 3.Oxidative stress quantified by measurement of malondialdehyde and 4- hydroxyalkenals, protein carbonyl, nitrites, total antioxidant status, melatonin, and activities of catalase, glutathione reductase, glutathione peroxidase, and superoxide dismutase. 4.Visual function assessed by Visual function best corrected visual acuity ETDRS scale or low vision ones, Funduscopy evaluation, Macular and Retinal Nerve Fiber Layer measured by Spectral Domain Optical Coherence Tomography, Electoretinogram (ERG) and automated perimetry. 5.Life quality evaluated by the National Eye Institute Visual Functioning Questionnaire.25 (NEI VFQ-25);Primary end point(s): -Sleep quality assessed by means of the Pittsburg Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Horne and Ostberg Morningness/Eveningness Questionnaire. -Life quality evaluated by the National Eye Institute Visual Functioning Questionnaire.25 (NEI VFQ-25) -Rest-activity cycles monitored by an actimeter that the patient wears like a wristwatch, recording the amount of movement made and the radiation of light received versus time. -Oxidative stress parameters measured in blood: a. Quantification of malondialdehyde and 4- hydroxyalkenals (MDA+4-HDA) by colorimetric methods. Blood levels of MDA+4-HDA are an index of lipid peroxidation. b. Protein carbonyl content: following the methodology of Levine. The protein carbonyl content is a marker of oxidative damage to proteins. c. Nitrites: by colorimetric method. Levels of nitrites formed after reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NO;Timepoint(s) of evaluation of this end point: NO | — |
Countries
Spain
Contacts
Public ContactEva López Hernández
Instituto Aragonés de Ciencias de la Salud
Outcome results
None listed