Sleep DisturbancePhase 1NCT05349188
Feasibility Study of Personalized Trials to Improve Sleep Quality
A Phase 1 study testing Melatonin 3 mg and Melatonin 0.5 mg in people with Sleep Disturbance, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Melatonin 3 mg and Melatonin 0.5 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 22 May 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Institute of Health System Science
New York, New York, 10022
About this study
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials: 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.
Read the detailed 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.
- Conditions
- Sleep Disturbance
- Being tested
- Melatonin 3 mg, Melatonin 0.5 mg, Cellulose placebo pill
- Keywords
- Sleep, Personalized, N-of-1, Virtual, Feasibility, Melatonin, Sleep Quality
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 3 mgDietary supplement
Participants will be provided with a smart pill bottle containing a 4-week supply of 3 mg melatonin pills.
Melatonin 0.5 mgDietary supplement
Participants will be provided with a smart pill bottle containing a 4-week supply of 0.5 mg melatonin pills.
Cellulose placebo pillOther
Participants will be provided with a smart pill bottle containing a 4-week supply of cellulose placebo pills.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Other: Cellulose placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement.
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.
Measured: Assessed across the two 14-day treatment periods (28 days total).
Mean Participant Adherence to Nightly Melatonin 3 mg Supplement.
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.
Measured: Assessed across the two 14-day treatment periods (28 days total).
Mean Participant Adherence to Nightly Placebo Supplement.
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.
Measured: Assessed across the two 14-day treatment periods (28 days total).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start11 May 2022
- Primary completion16 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM), Columbia University
- Responsible party
- Sponsor
- Investigators
- Karina Davidson, PhD, MASc, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349188
- Sponsor's protocol ID
- 21-0239
- Other IDs
- R01LM012836
- Status last verified
- Aug 2024
- First submitted
- 6 Apr 2022
- Last updated
- 22 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely. Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
Publications
Butler MJ, Chandereng T, Ahn H, Slotnick S, Miller D, Perrin A, Rodillas J, Friel CP, Goodwin AM, Cheung YK, Davidson KW. A Series of Personalized Melatonin Supplement Interventions for Poor Sleep: Feasibility Randomized Crossover Trial for Personalized N-of-1 Treatment. JMIR Form Res. 2025 Sep 26;9:e58192. doi: 10.2196/58192.
PubMed 41004640Butler 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.
PubMed 37535419
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials to Improve Sleep Quality
- ClinicalTrials.gov ID
- NCT05349188
- Acronym / sponsor ID
- 21-0239
- Conditions
- Sleep Disturbance
- Keywords
- Sleep, Personalized, N-of-1, Virtual, Feasibility, Melatonin, Sleep Quality
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM), Columbia University
- Study start
- 11 May 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Posted 22 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
| Arm | Type | Receives |
|---|---|---|
| Melatonin 3 mg | Experimental | Dietary Supplement: Melatonin 3 mgIndividuals 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). |
| Melatonin 0.5 mg | Active comparator | Dietary Supplement: Melatonin 0.5 mgIndividuals 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). |
| Placebo Pill | Placebo comparator | Other: Cellulose placebo pillIndividuals 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 3 mgParticipants will be provided with a smart pill bottle containing a 4-week supply of 3 mg melatonin pills. | Dietary supplement | Melatonin 3 mg |
| Melatonin 0.5 mgParticipants will be provided with a smart pill bottle containing a 4-week supply of 0.5 mg melatonin pills. | Dietary supplement | Melatonin 0.5 mg |
| Cellulose placebo pillParticipants will be provided with a smart pill bottle containing a 4-week supply of cellulose placebo pills. | Other | Placebo Pill |
Primary outcome
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.
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.
8 secondary outcomes
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).
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).
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).
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).
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).
Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement.
Time frame: Assessed across the two 14-day treatment periods (28 days total).
Mean Participant Adherence to Nightly Melatonin 3 mg Supplement.
Time frame: Assessed across the two 14-day treatment periods (28 days total).
Mean Participant Adherence to Nightly Placebo Supplement.
Time frame: Assessed across the two 14-day treatment periods (28 days total).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41004640Butler MJ, Chandereng T, Ahn H, Slotnick S, Miller D, Perrin A, Rodillas J, Friel CP, Goodwin AM, Cheung YK, Davidson KW. A Series of Personalized Melatonin Supplement Interventions for Poor Sleep: Feasibility Randomized Crossover Trial for Personalized N-of-1 Treatment. JMIR Form Res. 2025 Sep 26;9:e58192. doi: 10.2196/58192.
- Derived from this study: PubMed 37535419Butler 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.
- Individual participant dataSharing planned: Yes. All collected individual participant data (IPD) will be de-identified and pooled before sharing on the Open Science Framework, along with a data dictionary. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) Time Frame: The study protocol, including the statistical analysis plan, will be made available in addition to the informed consent form following completion of recruitment but prior to publication of any data from the current study. De-identified, pooled individual participant data will be made available within a year of final participant data collection. We anticipate this data to be available on the Open Science Framework platform indefinitely. Access Criteria: All data and supporting information will be stored on the Open Science Framework, a free web application with no access restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karina Davidson, PhD, MASc principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin 3 mg and Melatonin 0.5 mg in people with Sleep Disturbance, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.