Feasibility Study of Personalized Trials to Improve Sleep Quality

Completed · Phase 1 · Has a placebo group

Conditions studied: Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT05349188

Run by

Northwell Health

People needed

60

Starts

2022-05-11

Expected to finish

2023-05-22

Last updated by the study team

2024-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years
• Fluent in English
• Ability to take melatonin and a placebo
• Self-report of disrupted sleep symptoms using the Insomnia Symptom Questionnaire (ISQ)
• Owns and can regularly access a smartphone capable of receiving text messages
• Owns and can regularly access an e-mail account
• Lives in the United States
• Agreement to adhere to lifestyle considerations including wearing a Fitbit device day and night and potentially adapting their current melatonin routine to fit the protocol throughout study duration

You may not qualify if…

• Age < 18 years old
• Women who are pregnant or breastfeeding
• Individuals diagnosed with depression, seasonal affective disorder, schizophrenia, autoimmune disease, or asthma
• Individuals taking MAO inhibitors or corticosteroids
• Individuals diagnosed with low blood pressure
• Clinical diagnosis of a sleep disorder (e.g., Narcolepsy, Circadian Rhythm Sleep-Wake Disorders, Periodic Limb Movement Disorder, Restless Leg Syndrome, Obstructive Sleep Apnea etc.)
• Deemed unable to complete the study protocol as a result of cognitive impairment, severe medical or mental illness, or active or prior substance abuse
• Participation in shift work (evening/night shifts, early morning shifts, rotating shifts, etc.)
• Pilot or flight attendant with frequent travel across time zones
• Receiving specialty mental health care for insomnia (e.g., cognitive behavioral therapy for insomnia, medications for insomnia)
• Has even been told by a doctor or healthcare provider that it is not safe to take melatonin
• Does not own or cannot regularly access a smartphone capable of receiving text messages
• Does not possess or cannot regularly access an email account
• Lives outside the United States
• Planned surgeries within 6 months from study start date

Where it is running

• Institute of Health System Science — New York, New York, United States

Full record on ClinicalTrials.gov

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