circadian sleep-wake disturbances associated with ocular disease. MedDRA version: 21.1 Level: PT Classification code 10009191 Term: Circadian rhythm sleep disorder System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10009191 Term: Circadian rhythm sleep disorder System Organ Class:
Conditions
Interventions
Trade Name: Bio-melatonin
Product Name: Bio-melatonin
Product Code: N/A
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Bio
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be Male or Female aged 18 to 75. Participants identified as having a sleep problem as determined from their participation in the “Effect of Ocular Diseases on Sleep and ‘Body-Clocks’ (Circadian Rhythms)” study (REC Reference: B 11/SC/0093). These participants must have had abnormally elevated PSQI , and consented to be contacted for potential involvement in future research. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception (oral, patch, injected or implanted hormonal contraception, vaginal contraceptive ring, intra-uterine device or surgical sterilization, in addition to condom plus spermicide; or total sexual abstinence) during the trial and for 3 months thereafter. Participants are willing and able to give informed consent for participation in the trial. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: The participants may not enter the trial if ANY of the following apply: Non English speakers Currently taking medications which may affect sleep (i.e. sedatives, anti-histamines, antidepressants and hypnotics) unless anophthalmic. Previously taken medications which may affect sleep (i.e. sedatives, anti-histamines, antidepressants and hypnotics) within the last 2 months unless anophthalmic. Substance abuser Expecting to undergo a procedure involving anaesthetics during the study period Actively involved in night work during the study period IQ<70 as evidenced by medical notes and/or the opinion of the investigator. Pregnant or breast-feeding women Unlikely to cooperate in the study Unable to complete the protocol due to absences e.g. holiday or participants who may have potential jet lag. Significant urinary incontinence requiring regular use of pads History of liver or kidney disease History of sleep apnoea Hypersensitivity to bio-melatonin active substance or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the capability of melatonin to improve sleep-wake patterns in participants with various ocular diseases as compared to a placebo.;Secondary Objective: The secondary objective of the study is to assess the effect of melatonin administration on mood as compared to a placebo.; Primary end point(s): Comparison of sleep-wake patterns between groups using: 1. Pittsburgh Sleep Quality Index (PSQI) 2. Jupiter Sleep Questionnaire 3. General Health Questionnaire 4. SF-36 Questionnaire 5.Morningness-Eveningness (LARK/OWL) Questionnaire 6.Pictoral Epworth Sleepiness Scale 48 hour urine collection Sleep diary and actigraphy data ;Timepoint(s) of evaluation of this end point: End of treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of mood between groups as evidenced by Hospital Anxiety and Depression Scale (HADS) questionnaire ;Timepoint(s) of evaluation of this end point: End of treatment phase | — |
Countries
United Kingdom
Contacts
Public ContactColm Andrews
Oxford University Hospitals NHS Foundation Trust
Outcome results
None listed