A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease. - Melatonin treatment for sleep disturbance in ocular disorders:Sandman

niversity of Oxford0 个研究点目标入组 80 人开始时间: 2017年12月11日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•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

•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

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