Clinical trial NCT05349188: Feasibility Study of Personalized Trials to Improve Sleep Quality
Official title: Re-engineering Precision Therapeutics Through N-of-1 Trials: Feasibility Study of Personalized Trials to Improve Sleep Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Disturbance
Keywords: Sleep
Personalized
N-of-1
Virtual
Feasibility
Melatonin
Sleep Quality
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
name: Columbia University
First posted: 2022-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study utilizes a multiple crossover design to conduct N-of-1 trials in individuals.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean System Usability Score (SUS)
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
measure: Participant Satisfaction With Personalized Trial Components
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
Secondary outcomes:
measure: Within-Participant Difference in Fitbit Device-Recorded Sleep Duration.
timeFrame: 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).
measure: Mean Within-Subject Difference in Self-Reported Sleep Quality.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress.
timeFrame: 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).
measure: Mean Fitbit Device Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
measure: Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement.
timeFrame: Assessed across the two 14-day treatment periods (28 days total).
measure: Mean Participant Adherence to Nightly Melatonin 3 mg Supplement.
timeFrame: Assessed across the two 14-day treatment periods (28 days total).
measure: Mean Participant Adherence to Nightly Placebo Supplement.
timeFrame: Assessed across the two 14-day treatment periods (28 days total).
Other outcomes:
measure: Mean Within-Subject Difference in Self-Reported Sleep Disturbance.
timeFrame: Difference in self-reported sleep disturbance will be assessed every two weeks between baseline and intervention periods (14 weeks total).
measure: Within-Subject Difference in Self-Reported Side Effects.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Pain.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Mood.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Concentration.
timeFrame: 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).
measure: Within-Subject Difference in Ecological Momentary Assessment (EMA) of Confidence.
timeFrame: 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).
measure: Within-Subject Difference in Fitbit Device-Recorded Daily Steps.
timeFrame: 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).
measure: Mean Participant Survey Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
measure: Mean Participant Ecological Momentary Assessment (EMA) Adherence Rate.
timeFrame: Assessed once after the results report has been sent to the participant after completion of the trial (14 weeks from baseline).
Locations:
city: New York
country: United States
facility: Institute of Health System Science
state: New York
Study officials:
affiliation: Northwell Health
name: Karina Davidson, PhD, MASc
role: PRINCIPAL_INVESTIGATOR
References: