Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease
Background: 40% of Parkinson's Disease (PD) sufferers experience insomnia, impacting health and quality of life for patients and family members, especially carers. There is little evidence that current treatments are effective. Objectives: To determine the effectiveness of melatonin in reducing...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2019-09-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865419300122 |
| _version_ | 1818921259950407680 |
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| author | J. Nikles J.D. O'Sullivan G.K. Mitchell S.S. Smith J.M. McGree H. Senior N. Dissanyaka A. Ritchie |
| author_facet | J. Nikles J.D. O'Sullivan G.K. Mitchell S.S. Smith J.M. McGree H. Senior N. Dissanyaka A. Ritchie |
| author_sort | J. Nikles |
| collection | DOAJ |
| description | Background: 40% of Parkinson's Disease (PD) sufferers experience insomnia, impacting health and quality of life for patients and family members, especially carers. There is little evidence that current treatments are effective. Objectives: To determine the effectiveness of melatonin in reducing insomnia in 44 individuals with PD using N-of-1 trials. To aggregate group data to arrive at population estimates of effectiveness (measured by improvements in PDSS-2) and safety (measured by adverse events) of melatonin in improving insomnia in PD. To assess the feasibility of offering N-of-1 trials for insomnia in PD. Methodology: Participants will receive either immediate-release melatonin or placebo in random order in 3 paired two-week treatment periods (12 weeks total). Based on their response in a two-week run-in period on 3 mg daily, they will trial either 3 mg or 6 mg. Patients will keep daily sleep diaries and wear a MotionWatch throughout. After the trial patients will discuss their individual report with their doctor, which provides direct feedback about effectiveness and safety of melatonin for them. Statistical methods: We will analyse N-of-1 tests 1) individually: effects of melatonin on PDSS-2 and safety will be reported; and 2) aggregated across individual N-of-1 studies, combined using a Bayesian multilevel random effects model, which will account for repeated measures on individuals over time, and will return posterior estimates of overall treatment effect, and effect in each individual. Clinical Trial Registration number: ACTRN12617001103358. Keywords: N-of-1 trial, Parkinson's disease, Melatonin, Sleep, Insomnia |
| first_indexed | 2024-12-20T01:34:49Z |
| format | Article |
| id | doaj.art-2d7666e7c2284d4a978bdb653694460b |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-12-20T01:34:49Z |
| publishDate | 2019-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-2d7666e7c2284d4a978bdb653694460b2022-12-21T19:58:02ZengElsevierContemporary Clinical Trials Communications2451-86542019-09-0115Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's diseaseJ. Nikles0J.D. O'Sullivan1G.K. Mitchell2S.S. Smith3J.M. McGree4H. Senior5N. Dissanyaka6A. Ritchie7UQ Centre for Clinical Research, The University of Queensland, Brisbane, Australia; Corresponding author.Royal Brisbane & Women's Hospital (RBWH), Neurology Department, School of Medicine, St Andrew's, Wesley and RBWH Hospitals, The University of Queensland, Brisbane, AustraliaGeneral Practice and Palliative Care, School of Medicine, The University of Queensland, Brisbane, AustraliaInstitute for Social Science Research (ISSR), The University of Queensland, Brisbane, AustraliaSchool of Mathematical Sciences, Queensland University of Technology, Brisbane, AustraliaHuman Biology and Health, College of Health, Massey University, Auckland, New ZealandThe University of Queensland, Brisbane, AustraliaSt Andrew's War Memorial Hospital, Royal Brisbane and Women's Hospital, Brisbane, AustraliaBackground: 40% of Parkinson's Disease (PD) sufferers experience insomnia, impacting health and quality of life for patients and family members, especially carers. There is little evidence that current treatments are effective. Objectives: To determine the effectiveness of melatonin in reducing insomnia in 44 individuals with PD using N-of-1 trials. To aggregate group data to arrive at population estimates of effectiveness (measured by improvements in PDSS-2) and safety (measured by adverse events) of melatonin in improving insomnia in PD. To assess the feasibility of offering N-of-1 trials for insomnia in PD. Methodology: Participants will receive either immediate-release melatonin or placebo in random order in 3 paired two-week treatment periods (12 weeks total). Based on their response in a two-week run-in period on 3 mg daily, they will trial either 3 mg or 6 mg. Patients will keep daily sleep diaries and wear a MotionWatch throughout. After the trial patients will discuss their individual report with their doctor, which provides direct feedback about effectiveness and safety of melatonin for them. Statistical methods: We will analyse N-of-1 tests 1) individually: effects of melatonin on PDSS-2 and safety will be reported; and 2) aggregated across individual N-of-1 studies, combined using a Bayesian multilevel random effects model, which will account for repeated measures on individuals over time, and will return posterior estimates of overall treatment effect, and effect in each individual. Clinical Trial Registration number: ACTRN12617001103358. Keywords: N-of-1 trial, Parkinson's disease, Melatonin, Sleep, Insomniahttp://www.sciencedirect.com/science/article/pii/S2451865419300122 |
| spellingShingle | J. Nikles J.D. O'Sullivan G.K. Mitchell S.S. Smith J.M. McGree H. Senior N. Dissanyaka A. Ritchie Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease Contemporary Clinical Trials Communications |
| title | Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease |
| title_full | Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease |
| title_fullStr | Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease |
| title_full_unstemmed | Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease |
| title_short | Protocol: Using N-of-1 tests to identify responders to melatonin for sleep disturbance in Parkinson's disease |
| title_sort | protocol using n of 1 tests to identify responders to melatonin for sleep disturbance in parkinson s disease |
| url | http://www.sciencedirect.com/science/article/pii/S2451865419300122 |
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