Melatonin treatment for sleep disturbance in eye disorders: Sandman Trial

Phase 1

• Conditions: 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; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2017-002189-39-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified