Not Yet RecruitingPhase 4ACTRN12617001103358

Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson’s Disease

Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's Disease

Sponsor

University of Queensland

Enrollment

44 participants

Start Date

Aug 31, 2018

Study Type

Interventional

Conditions

Insomnia Parkinson's Disease

Summary

This study aims to see whether using melatonin assists with sleeping in patients with Parkinson’s Disease.IMET stands for Individual Medication Effectiveness Tests. An IMET is a new way of working out whether the medication is working for the individual taking the medicine. Most projects that test the effectiveness of medicines give information about the effects of that medication on groups of people. IMETs give information about the effectiveness of the medicine only for the person doing the test. The IMET will take twelve weeks, and use active and placebo (inactive) medication. Placebo and active medication look exactly the same, but the placebo is not active and has no effect. The IMET team will arrange things so that neither you nor your study doctor, will know what medication you will be taking at any one time. But everyone will know that you will be taking either medication for periods of two weeks at a time, and in a random order.

Eligibility

Sex: Both males and femalesMin Age: 30 Yearss

Inclusion Criteria10

Adult patients 30 years or more with a diagnosis of idiopathic PD according to the UK Brain Bank (Hughes et al, 1992)
Patient has claimed chronic sleep difficulty which is impacting his/her life.
Score > 5 on the Pittsburgh Sleep Quality Index (PSQI) (Buysse D et al, 1989)
If on sedatives or hypnotics, agree not to alter the daily dose of these for the duration of the test.
If not on regular sedatives or hypnotics, agree not to commence these treatments during the test.
If on Parkinson’s disease or psychotropic medication, doses stable for 1 month before and throughout the course of the study.
Able to provide informed consent.
Able to understand English.
Have a phone.
Agree not to drive or operate heavy machinery within 8 hours of ingestion of study medication.

Exclusion Criteria14

Scores < 28 in Telephone Interview Cognitive Status (TICS) (Brandt J et al, 1988)
Has diagnosed sleep apnea or high risk of this (2 or more categories where the score is positive on Berlin questionnaire for sleep apnea risk (Netzer et al, 1999)).
Co-morbid psychiatric/neurological diagnoses that may affect sleep, including:
Acquired brain injury
Uncontrolled major depression
Active or untreated post-traumatic stress disorder
Uncontrolled psychosis or schizophrenia
Unstable seizure disorder (i.e. seizure in the last 12 months)
Other relevant medical diseases, malignancy or other progressive neurological
disorder
Cognitive impairment defined by Standardised Mini Mental State Score < 25/30 (Molloy and Standish, 1997).
Known allergy or hypersensitivity to melatonin or previous adverse event from melatonin.
Contraindications to melatonin, such as on immunosuppressive drugs or anticoagulant drugs; patients with active or uncontrolled hormonal disorders, or diabetes, or significant active liver disease (determined by clinician), or moderate-severe abnormal kidney function (determined by clinician) or untreated kidney disease, or any blood clotting disorders.
Breastfeeding or pregnant women.

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Interventions

clinical trial that involves a single patient, with the patient serving as their own control. N-of-1 trials, or tests, use a multi-cycle, double-blind, randomized controlled trial (RCT) design where

clinical trial that involves a single patient, with the patient serving as their own control. N-of-1 trials, or tests, use a multi-cycle, double-blind, randomized controlled trial (RCT) design where each participant is assured of receiving both the study medication and placebo, and thus learns whether the treatment works specifically for him or her.Each participant will undergo 3 pairs of treatment/placebo periods (each period is 2 weeks; each N-of-1 test will last 12 weeks). Treatments will be randomized separately within each pair of periods (e.g. ABBAAB) by the study statistician.Data from day 1 will be discarded to provide a washout period.There will be a two week run-in period, on 3 mg melatonin.Standard scripts will cover dispensing a two week supply of 3 mg melatonin to the patient. Medication instructions will be explained. We will ask patients to complete a sleep diary (with baseline and weekly administration of the PDSS-2) during the two weeks on 3 mg. If the participant’s PDSS-2 scores improve, the test dose will be 3 mg; if the score does not improve, the test dose will be 6 mg. We will use a threshold of -3.44 points change in the PDSS-2 for detecting clinically significant improvement. Patients, clinicians, research staff and outcome assessors will be blinded. Participants will take either immediate release melatonin or placebo 30 mins before bedtime. Two doses will be available (3 mg or 6 mg) in personalised N-of-1 tests. For both doses, the comparator will be placebo. trial medications are prepared in oral capsule and will be administered sublingual. Patients will be asked about progress, any queries and adverse events weekly by the RN during follow up phone calls.