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Feasibility Study of Personalized Trials to Improve Sleep Quality

NCT05349188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-08-22

Study results available
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Summary

The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study of melatonin intervention for poor sleep quality. Participants (N=60) will be sent a Fitbit device and 3 smart pill bottles, with one containing 3 mg of melatonin, one containing 0.5 mg of melatonin, and the final bottle containing a placebo pill. The first two weeks will be a baseline period, where no supplement is assigned, but data are collected, including self-report of sleep quality and duration and accelerometer-derived sleep and activity data. After successful completion of the baseline period, participants will be randomized to six 2-week intervention blocks of a 3 mg dose melatonin, a 0.5 mg dose melatonin, and a placebo. At the end of the trial, participants will be asked to complete the System Usability Scale, a satisfaction survey (electronic or phone/video call if they are non-responders), and participate in a virtual interview (such as over Microsoft Teams or a phone call) to inform feasibility and acceptability of protocol requirements, study materials, and personalized reports.

Conditions

  • Sleep Disturbance

Interventions

DIETARY_SUPPLEMENT

Melatonin 3 mg

Participants will be provided with a smart pill bottle containing a 4-week supply of 3 mg melatonin pills.

DIETARY_SUPPLEMENT

Melatonin 0.5 mg

Participants will be provided with a smart pill bottle containing a 4-week supply of 0.5 mg melatonin pills.

OTHER

Cellulose placebo pill

Participants will be provided with a smart pill bottle containing a 4-week supply of cellulose placebo pills.

Sponsors & Collaborators

  • National Library of Medicine (NLM)

    collaborator NIH

  • Columbia University

    collaborator OTHER

  • Northwell Health

    lead OTHER

Principal Investigators

  • Karina Davidson, PhD, MASc · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2023-05-16
Completion
2023-05-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05349188 on ClinicalTrials.gov