Phase 1
Completed N=60
Feasibility Study of Personalized Trials to Improve Sleep Quality
Source: ClinicalTrials.gov NCT05349188 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Mean System Usability Score (SUS) — 76.27 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean System Usability Score (SUS) |
76.27 | — |
| PRIMARY Participant Satisfaction With Personalized Trial Components |
4.04; 4.40; 3.67; 3.47; 4.58; 4.51 | — |
| SECONDARY Within-Participant Difference in Fitbit Device-Recorded Sleep Duration. |
399; 402; 398; 398 | — |
| SECONDARY Mean Within-Subject Difference in Self-Reported Sleep Quality. |
3.13; 3.35; 3.44; 3.38 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Fatigue. |
3.85; 3.58; 3.49; 3.44 | — |
| SECONDARY Within-Subject Difference in Ecological Momentary Assessment (EMA) of Stress. |
3.19; 3.34; 3.29; 3.33 | — |
| SECONDARY Mean Fitbit Device Adherence Rate. |
88.01 | — |
| SECONDARY Mean Participant Adherence to Nightly Melatonin 0.5 mg Supplement. |
21.82 | — |
| SECONDARY Mean Participant Adherence to Nightly Melatonin 3 mg Supplement. |
21.78 | — |
| SECONDARY Mean Participant Adherence to Nightly Placebo Supplement. |
21.53 | — |
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
Data sourced from ClinicalTrials.gov (NCT05349188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.