Feasibility Study of Personalized Trials to Improve Sleep Quality

NCT05349188 | Completed Phase 1 Results DMC

• 2 other identifiers: 21-0239R01LM012836
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep; Personalized; N-of-1; Virtual; Feasibility; Melatonin; Sleep Quality

Outcome Measures

Primary Outcomes (2)

• Mean System Usability Score (SUS)

  The SUS is a validated 10-item questionnaire that asks users to score each item on a Likert scale from Strongly Disagree (rating of 1) to Strongly Agree (rating of 5). The SUS will be presented to the participant as addressing the ease of use, complexity, consistency of the Personalized Trials system as a whole, from recruitment to receipt of the report. Individual results are calculated to arrive at a composite measure out of 100. Participant SUS scores will be averaged together and an overall mean will be reported with standard deviation. Higher scored values correlate to a more usable system, and therefore a better outcome.

  Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).

• Participant Satisfaction With Personalized Trial Components

  Participants will rate their satisfaction with the Personalized N-of-1 Trial overall and with individual elements of the trial in a satisfaction survey administered following the baseline and intervention periods (14 weeks). Means and standard deviations will be reported for each element of satisfaction. Participants will rate their satisfaction on a scale of 1 to 5, with higher scores indicating greater levels of satisfaction.

  Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).

Secondary Outcomes (8)

• Within-Participant Difference in Fitbit Device-Recorded Sleep Duration.

  Nightly sleep duration will be assessed consistently via Fitbit device during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).

• Mean Within-Subject Difference in Self-Reported Sleep Quality.

  Daily sleep quality will be assessed daily via survey during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each).

• Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.

  EMA fatigue will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).

• Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.

  EMA stress will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).

• Mean Fitbit Device Adherence Rate.

  Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).

Other Outcomes (9)

• Mean Within-Subject Difference in Self-Reported Sleep Disturbance.

  Difference in self-reported sleep disturbance will be assessed every two weeks between baseline and intervention periods (14 weeks total).

• Within-Subject Difference in Self-Reported Side Effects.

  Self-reported side effects will be assessed via weekly survey during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).

• Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.

  EMA pain will be assessed 3 times daily via text message during the baseline assessment period (2 weeks) and during each of the 6 intervention periods (2 weeks each, 12 weeks total).

Study Arms (3)

Melatonin 3 mg

EXPERIMENTAL

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).

Dietary Supplement: Melatonin 3 mg

Melatonin 0.5 mg

ACTIVE COMPARATOR

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).

Dietary Supplement: Melatonin 0.5 mg

Placebo Pill

PLACEBO COMPARATOR

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).

Other: Cellulose placebo pill

Interventions

Melatonin 3 mg DIETARY_SUPPLEMENT

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

Melatonin 3 mg

Melatonin 0.5 mg DIETARY_SUPPLEMENT

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

Melatonin 0.5 mg

Cellulose placebo pill OTHER

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

Placebo Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Northwell Health: lead
• National Library of Medicine (NLM): collaborator
• Columbia University: collaborator

Study Sites (1)

Institute of Health System Science

New York, New York, 10022, United States

Location

Related Publications (1)

• Butler M, D'Angelo S, Perrin A, Rodillas J, Miller D, Arader L, Chandereng T, Cheung YK, Shechter A, Davidson KW. A Series of Remote Melatonin Supplement Interventions for Poor Sleep: Protocol for a Feasibility Pilot Study for a Series of Personalized (N-of-1) Trials. JMIR Res Protoc. 2023 Aug 3;12:e45313. doi: 10.2196/45313.

  PMID: 37535419 DERIVED

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Mark Butler, PhD
• Organization: Northwell Health

markbutler@northwell.edu

908-414-0238

Study Officials

• Karina Davidson, PhD, MASc

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to the intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 27, 2022
• Study Start: May 11, 2022
• Primary Completion: May 16, 2023
• Study Completion: May 22, 2023
• Last Updated: August 22, 2024
• Results First Posted: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)