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Completed

NCT Number: NCT05349188

Feasibility Study of Personalized Trials to Improve Sleep Quality

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.

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Key information

Conditions

Sleep Disturbance Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Health System Science

New York, 10022, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Cellulose placebo pill

Other

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

Primary outcomes

  1. Mean System Usability Score (SUS)

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

    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.

  2. Participant Satisfaction With Personalized Trial Components

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

    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.

Secondary outcomes

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

    Time frame: 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).

    Nightly sleep duration will be assessed by a Fitbit wearable device. Sleep duration will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Sleep duration values over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

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

    Time frame: 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).

    Participants will rate their sleep disturbance using a modified version of the Consensus Sleep Diary administered daily during baseline and intervention periods (14 weeks). Participants will be asked to rate their sleep on a 5-point scale rated from "very poor" to "very good". Levels of daily sleep quality will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period, with higher scores indicating better sleep quality. Changes in sleep quality over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

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

    Time frame: 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).

    Fatigue will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(low) to 10(high). Levels of EMA fatigue will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA fatigue over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

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

    Time frame: 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).

    Stress will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their stress on a scale of 0(low) to 10(high). Levels of EMA stress will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA stress over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  5. Mean Fitbit Device Adherence Rate.

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

    For each participant, the proportion of days where the Fitbit device was worn will be calculated. Proportion of days where the Fitbit device was worn across all participants will be reported with means and standard deviations.

  6. Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement.

    Time frame: Assessed across the two 14-day treatment periods (28 days total).

    For each participant, the proportion of days where the melatonin 0.5 mg supplement was administered will be calculated. Proportion of days adherent across all participants will be reported with means and standard deviations.

  7. Mean Participant Adherence to Nightly Melatonin 3 mg Supplement.

    Time frame: Assessed across the two 14-day treatment periods (28 days total).

    For each participant, the proportion of days where the melatonin 3 mg supplement was administered will be calculated. Proportion of days adherent across all participants will be reported with means and standard deviations.

  8. Mean Participant Adherence to Nightly Placebo Supplement.

    Time frame: Assessed across the two 14-day treatment periods (28 days total).

    For each participant, the proportion of days where the placebo supplement was administered will be calculated. Proportion of days adherent across all participants will be reported with means and standard deviations.

Other outcomes

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

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

    Participants will rate their sleep disturbance using the Insomnia Severity Index (ISI) administered daily during baseline and intervention periods (14 weeks). Items are rated from 0 to 4, with higher scores indicating greater levels of sleep disturbance. Levels of daily sleep disturbance will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in sleep disturbance over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

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

    Time frame: 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).

    Participant self-reported side effects will be assessed utilizing a weekly survey measure. Number of side effects will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate a count of self-reported side effects in each study period. Side effects over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

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

    Time frame: 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).

    . Pain will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their pain on a scale of 0(low) to 10(high). Levels of EMA pain will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA pain over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  4. Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.

    Time frame: EMA mood 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).

    Mood will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(poor) to 10(excellent). Levels of EMA mood will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA mood over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  5. Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.

    Time frame: EMA concentration 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).

    Concentration will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(low) to 10(high). Levels of EMA concentration will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA concentration over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  6. Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.

    Time frame: EMA confidence 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).

    Confidence will be assessed via 3 daily text message prompts sent at random times throughout the day asking individuals to rate their fatigue on a scale of 0(low) to 10(high). Levels of EMA confidence will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Changes in EMA confidence over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  7. Within-Subject Difference in Fitbit Device-Recorded Daily Steps.

    Time frame: Daily steps 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).

    . Daily step counts will be assessed by a Fitbit device. Daily step counts will be aggregated within the baseline assessment period and in each of the intervention periods (3 mg melatonin, 0.5 mg melatonin, placebo) to generate an overall mean and standard deviation for each period. Daily steps values over the course of the study will be evaluated using Generalized Linear Mixed Model analyses.

  8. Mean Participant Survey Adherence Rate.

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

    For each participant of the proportion of surveys measures completed (both daily and weekly surveys) will be calculated. Proportion of days adherent across all participants will be reported with means and standard deviations.

  9. Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.

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

    For each participant of the proportion of EMA measures completed will be calculated. Proportion of days adherent across all participants will be reported with means and standard deviations.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Columbia University
  • National Library of Medicine (NLM)

Registry information

Official study title

Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials to Improve Sleep Quality

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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