Status:
COMPLETED
Feasibility Study of Personalized Trials to Improve Sleep Quality
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
National Library of Medicine (NLM)
Columbia University
Conditions:
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Fi...
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 plac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05349188
Start Date
May 11 2022
End Date
May 22 2023
Last Update
August 22 2024
Active Locations (1)
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1
Institute of Health System Science
New York, New York, United States, 10022