Sleep Problems
Conditions
Brief summary
Sleep is a major public health concern in the United States. Major guidelines recommend that adults obtain at least 7 hours of sleep per night. More than 25% of U.S. adults do not meet this recommendation, and 14.5% report difficulty falling asleep on most days or every day during the past month. The investigators developed a low-cost, easily accessible sleep intervention using artificial intelligence (AI) technologies. The purpose of this study is to examine the effect of this intervention on sleep outcomes among U.S. adults.
Detailed description
After providing informed consent, participants will complete a baseline assessment and then be randomized to either the AI chatbot intervention or a waitlist control. The intervention group will receive immediate access to the AI-powered sleep chatbot for 2 weeks, while the waitlist control group will continue their usual sleep habits without chatbot access. Following the post-intervention assessment, participants in the waitlist control group will receive access to the chatbot. Follow-up assessments will be conducted at 3 and 6 months after randomization.
Interventions
BEHAVIORALAI-based chatbot
Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion
Sponsors
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years * had a raw score of 23 or higher on the Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance * had a smartphone and be able to access the internet * willing and able to participate through text messages on a smartphone * able to read and understand English
Exclusion criteria
* pregnant or lactating * concurrently participating in other research studies focused on lifestyle modifications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit-measured sleep duration | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Sleep duration will be measured objectively using Fitbit and defined as the total amount of time spent asleep during the primary sleep period, expressed in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fitbit-measured sleep onset | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Sleep onset will be measured objectively using Fitbit and defined as the time from attempting to fall asleep to sleep onset, expressed in minutes. |
| Fitbit-measured sleep efficiency | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Sleep efficiency will be measured objectively using Fitbit and defined as the percentage of time spent asleep while in bed, expressed as a percentage (%). |
| Fitbit-measured wake after sleep onset | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Wake after sleep onset will be measured objectively using Fitbit and defined as the total amount of time participants are awake after initially falling asleep until the final awakening, expressed in minutes. |
| Perceived sleep quality | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Perceived sleep quality measured by the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality. |
| Daytime sleepiness | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Daytime sleepiness will be measured using the Epworth Sleepiness Scale. The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. |
| Sleep hygiene | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Sleep hygiene will be measured using the Sleep Hygiene Index. The total score ranges from 13 to 65, with a higher score indicating poorer sleep hygiene (a worse outcome). |
| Sleep environment | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Sleep Environment measured by the Assessment of Sleep Environment |
| Number of awakenings | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Number of awakenings will be measured objectively using Fitbit and defined as the total number of wake episodes occurring during the primary sleep period, expressed as the number of awakenings. |
| Light sleep duration | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Light sleep duration will be measured objectively using Fitbit and defined as the total time spent in the light sleep stage during the primary sleep period, expressed in minutes. |
| Deep sleep duration | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Deep sleep duration will be measured objectively using Fitbit and defined as the total time spent in the deep sleep stage during the primary sleep period, expressed in minutes. |
| Rapid eye movement sleep duration | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Rapid eye movement sleep duration will be measured objectively using Fitbit and defined as the total time spent in the rapid eye movement sleep stage during the primary sleep period, expressed in minutes. |
| Wake duration | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Wake duration will be measured objectively using Fitbit and defined as the total time spent awake during the primary sleep period, expressed in minutes. |
| Dysfunctional beliefs and attitudes about sleep | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Dysfunctional beliefs and attitudes about sleep will be measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16). The total scores range from 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep. |
| Perceived stress | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Perceived stress will be measured using the Perceived Stress Scale-4. The total score ranges from 0 to 16, with a higher score indicating greater perceived stress. |
| Anxiety | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Anxiety will be measured using the Generalized Anxiety Disorder-2. The total score ranges from 0 to 6, with a higher score indicating greater anxiety symptom severity. |
| Fatigue | Baseline, 2-week post-intervention, and 3- and 6-month follow-ups | Fatigue will be measured using the Fatigue Severity Scale. The total score ranges from 1 to 7, with a higher score indicating greater fatigue severity. |
Countries
United States
Contacts
CONTACTLiu
Outcome results
None listed