Feasibility Study of Personalized Trials to Improve Sleep Quality

Northwell Health

Status and phase: Completed; Phase 1

Conditions: Sleep Disturbance

Treatments: Dietary Supplement: Melatonin 0.5 mg; Other: Cellulose placebo pill; Dietary Supplement: Melatonin 3 mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05349188

21-0239

R01LM012836 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The purpose of this pilot study is to assess the feasibility of using N-of-1 methods in a virtual research study; to remotely recruit and enroll participants; to assess the feasibility of using a placebo and to determine the feasibility of the proposed methods used to collect and assess participant adherence and response to a wellness strategy (in this case, melatonin for poor sleep quality). This pilot will help determine if an N-of-1 study design, or what has been termed 'Personalized Trials', can have widespread use in future research and clinical practice to address high public health burdens with a high heterogeneity of response. This pilot study will assess feasibility using a Personalized Trials model to evaluate an individual participant's experience with a wellness strategy for self-reported 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 placebo pills. Participants will be asked several questions a day sent via text message about their sleep quality, as well as their stress, fatigue, concentration, confidence, mood, and pain levels to demonstrate relevant secondary impacts of sleep quality. Participants will also have access to several videos explaining the protocol. The study will take place over the course of 14 weeks. 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 14 weeks, a report containing the individual's observed data will be prepared for each participant and electronically sent to them along with a satisfaction survey (electronic, or phone/video call if they are non-responders).

After the end of the 14-week trial, participants will receive a summary of their observed data in a personalized report. Creating this type of report will help to assess the feasibility of using a N-of-1 trial design through user-acceptability of sleep quality and wellness-related data visualizations, and the ability to choose preferred intervention (if any) based on the data. 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 3 patient groups, including a placebo group

Melatonin 3 mg

Experimental group

Description:

Individuals will receive a kit with medication adherence devices containing melatonin 3 mg in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the 3mg of melatonin. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive melatonin 3 mg, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The melatonin 3 mg intervention will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).

Treatment:

Dietary Supplement: Melatonin 3 mg

Melatonin 0.5 mg

Active Comparator group

Description:

Individuals will receive a kit with medication adherence devices containing melatonin 0.5 mg in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the 0.5 mg of melatonin. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive melatonin 0.5 mg, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The melatonin 0.5 mg intervention will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).

Treatment:

Dietary Supplement: Melatonin 0.5 mg

Placebo Pill

Placebo Comparator group

Description:

Individuals will receive a kit with medication adherence devices containing the placebo pills in one of three smart electronic pill bottles labeled "A," "B," and "C." Participants will not be aware which of the pill bottles contains the placebo. Participants will be randomized to take pills in 6 alternating intervention periods 2 weeks in length. During periods where participants were randomized to receive the placebo, they will receive a nightly text notification 1 hour before bed instructing them to take a pill from the corresponding smart pill bottle. The placebo will be administered in 2 intervention periods each 2 weeks in length (4 weeks total).

Treatment:

Other: Cellulose placebo pill