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Poor Sleep QualityNCT07850687

Improving Sleep Health for Asian Americans

A study testing Intervention Group in people with Poor Sleep Quality and Short Sleep, run by New York University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Filipino Americans are at high risk of poor sleep and its adverse health consequences. The goal of this study is to test a generative AI-powered chatbot that delivers personalized, evidence-based sleep education and guidance to Filipino Americans who experience poor sleep. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Poor Sleep Quality, Short Sleep
What is being tested?
Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 29 Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 30 to 70 years
  • Self-identify as having a Filipino background and reside in the United States
  • Poor sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score ≥ 5
  • Short sleep duration, defined as an average Fitbit-measured total sleep time < 7 hours/night over 7 days
  • Able to speak and read English
  • Willing to engage with the chatbot via text messaging

Who cannot join

  • Severe mental disorders, including major depressive symptoms
  • Medical conditions, including cognitive impairment, that may interfere with the ability to follow study procedures
  • Current participation in another lifestyle intervention
  • Night-shift or rotating-shift worker
  • Alcohol or substance abuse
  • Use of sleep medications more than 3 times per week

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaoyue Liu, PhD contact

2129925994

xl5272@nyu.edu

United States1 site
  • New York University

    New York, New York, 10010

    Asian American Sleep Health Study, 3479170118, aa-sleephealth@nyu.edu

Other trials in United States

About this study

Official title: Pilot Testing a Sleep Intervention Among Filipino American Adults

Filipino Americans are at high risk of poor sleep and its adverse health consequences. The goal of this study is to test a generative AI-powered chatbot that delivers personalized, evidence-based sleep education and guidance to Filipino Americans who experience poor sleep.

Being tested
Intervention Group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention GroupBehavioural

    Participants engage with an AI chatbot for two weeks to learn personalized education and skills regarding sleep promotion

Study groups in NCT07850687
Study groupRoleWhat they receive
InterventionExperimentalParticipants will receive access to an AI-based chatbot and engage with it via text messaging for 2 weeks.
Receives: Behavioral: Intervention Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention retention

    Percentage of participants who complete the 2-week sleep intervention

    Measured: From enrollment to 2-week post-intervention

Secondary outcomes (21)
  1. Feasibility of recruitment

    Percentage of adults who meet the study criteria

    Measured: From screening to baseline

  2. Feasibility of study enrollment

    Percentage of eligible participants who provide consent

    Measured: From screening to enrollment

  3. Feasibility of completing the study assessment

    Percentage of enrolled participants who complete the baseline assessment

    Measured: From enrollment to baseline

  4. Feasibility of completing the study assessment

    Percentage of enrolled participants who complete the post-intervention assessment

    Measured: From enrollment to 2-week post-intervention

  5. Intervention acceptability

    Satisfaction with the intervention will be measured by the Client Satisfaction Questionnaire-8. The total score ranges from 8 to 32, with higher scores indicating greater satisfaction with the intervention.

    Measured: 2-week post-intervention

  6. Intervention engagement

    Total days of engaging with the chatbot

    Measured: 2-week post-intervention, 2-month follow-up, and 4-month follow-up

  7. Intervention engagement

    Total duration of engaging with the chatbot

    Measured: 2-week post-intervention, 2-month follow-up, and 4-month follow-up

  8. Intervention engagement

    Message exchanges per chat session

    Measured: 2-week post-intervention, 2-month follow-up, and 4-month follow-up

  9. Intervention usability

    Usability of the intervention will be measured by the Chatbot Usability Questionnaire. The total score ranges from 0 to 100. Higher scores indicate greater perceived chatbot usability.

    Measured: 2-week post-intervention

  10. Fitbit-measured sleep duration

    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.

    Measured: Baseline, 2-week post-intervention

  11. Fitbit-measured sleep onset

    Sleep onset will be measured objectively using Fitbit and defined as the time from attempting to fall asleep to sleep onset, expressed in minutes.

    Measured: Baseline, 2-week post-intervention

  12. Fitbit-measured sleep efficiency

    Sleep efficiency will be measured objectively using Fitbit and defined as the percentage of time spent asleep while in bed, expressed as a percentage (%).

    Measured: Baseline, 2-week post-intervention

  13. Fitbit-measured wake after sleep onset

    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.

    Measured: Baseline, 2-week post-intervention

  14. Fitbit-measured number of awakenings

    Wake after sleep onset will be measured objectively using Fitbit and defined as the total count of times a person fully wakes up or regains consciousness after initially falling asleep during a sleep period

    Measured: Baseline, 2-week post-intervention

  15. Fitbit-measured light sleep duration

    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.

    Measured: Baseline, 2-week post-intervention

  16. Fitbit-measured deep sleep duration

    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.

    Measured: Baseline, 2-week post-intervention

  17. Fitbit-measured rapid eye movement sleep duration

    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.

    Measured: Baseline, 2-week post-intervention

  18. Perceived sleep quality

    Perceived sleep quality will be measured by the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.

    Measured: Baseline, 2-week post-intervention, 2-month follow-up, 4-month follow-up

  19. Daytime sleepiness

    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.

    Measured: Baseline, 2-week post-intervention

  20. Dysfunctional beliefs and attitudes about sleep

    Dysfunctional beliefs and attitudes about sleep will be measured using the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16). The total score ranges from 0 to 10, with a higher score indicating more dysfunctional beliefs and attitudes about sleep.

    Measured: Baseline, 2-week post-intervention

  21. Sleep hygiene

    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)

    Measured: Baseline, 2-week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion29 Feb 2028 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07850687
Sponsor's protocol ID
FY2027-11918
Other IDs
1R21MD020471-01A1
Status last verified
Sep 2026
First submitted
24 Sep 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect participants' personal information and privacy

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group in people with Poor Sleep Quality and Short Sleep, run by New York University 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 2 Oct 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaoyue Liu, PhD (2129925994, xl5272@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention retention (time frame: From enrollment to 2-week post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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