A Series of Personalized Melatonin Supplement Interventions for Poor Sleep: Feasibility Randomized Crossover Trial for Personalized N-of-1 Treatment
Abstract
Background: Poor sleep (defined by short sleep duration or poor quality) is a common condition with potential serious health consequences. Exogenous melatonin supplements have been found to effectively improve poor sleep but have also been shown to have heterogeneity of treatment effects (HTEs) between individuals. Personalized N-of-1 trials, in which each participant is the unit of analysis, are ideal for identifying whether a treatment with high HTE is beneficial for each individual patient.
Objective: This study aimed to identify the feasibility, acceptability, and effectiveness of a series of personalized N-of-1 trials of melatonin for poor sleep.
Methods: This study consisted of 60 digital, personalized N-of-1 crossover trials comparing the effects of 3.0 mg and 0.5 mg of melatonin versus placebo for poor sleep with randomization to 1 of 2 orders. The trial comprised a 2-week baseline period and a 12-week intervention period. The primary outcomes were usability of the personalized trial system (measured using the System Usability Scale [SUS]) and participant satisfaction with the trial. Effectiveness outcomes included sleep duration (measured using a Fitbit activity tracker [Google]) and sleep quality (measured using the consensus sleep diary).
Results: Participants rated the usability of the personalized trial as acceptable (average SUS score 76.3, SD 17.1), and 96% (55/57) of those who completed satisfaction surveys stated that they would recommend the trial to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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