InsomniaFireflyNCT06840444
Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep
An observational study of Insomnia and Adolescent, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Insomnia, Adolescent, Digital Health
- What is being tested?
- Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth with self-reported insomnia symptoms, aged 13-18.
Who may be able to join
- 13-18 years old
- Self-reported insomnia symptoms
Who cannot join
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas University Medical Center
Kansas City, Kansas, 66103
About this study
Official title: The Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.
Read the detailed description
The aims of this study are to: 1) form a Teen Advisory Board (TAB) of teens with self-reported insomnia symptoms, 2) co-design a functional app prototype for sleep with TAB, 3) conduct two rounds of beta-testing to inform the iterative refinement of the app prototype. Participants will include 40 youth and their parents; 10 youth will participate in the TAB and first round 1 of beta-testing, and a separate cohort of 30 youth will participate in a second round of beta-testing. Youth will be ages 13-18 years and will have self-reported insomnia symptoms.
- Conditions
- Insomnia, Adolescent, Digital Health
- Being tested
- Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firefly Mobile App: A Digital Health Solution for Healthy Sleep in TeensBehavioural
A six week cognitive behavioral therapy for insomnia program delivered via a mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Teen Advisory Board (TAB)/Beta Cohort 1 | These teens will co-design and beta-test an app prototype. Receives: Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens | |
| Beta Cohort 2 | These teens will do the second round of beta-testing for the app prototype. Receives: Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Completion Percentage
Measured: Immediately post-treatment
Secondary outcomes (1)
Treatment Acceptability Ratings
Measured: Immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion1 Dec 2025
Why it stopped: No longer pursuing a trial for this project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840444
- Sponsor's protocol ID
- STUDY00161292
- Acronym
- Firefly
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
- ClinicalTrials.gov ID
- NCT06840444
- Acronym / sponsor ID
- Firefly / STUDY00161292
- Conditions
- Insomnia, Adolescent, Digital Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No longer pursuing a trial for this project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens. This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.
Detailed description
The aims of this study are to: 1) form a Teen Advisory Board (TAB) of teens with self-reported insomnia symptoms, 2) co-design a functional app prototype for sleep with TAB, 3) conduct two rounds of beta-testing to inform the iterative refinement of the app prototype. Participants will include 40 youth and their parents; 10 youth will participate in the TAB and first round 1 of beta-testing, and a separate cohort of 30 youth will participate in a second round of beta-testing. Youth will be ages 13-18 years and will have self-reported insomnia symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Advisory Board (TAB)/Beta Cohort 1 | – | Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in TeensThese teens will co-design and beta-test an app prototype. |
| Beta Cohort 2 | – | Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in TeensThese teens will do the second round of beta-testing for the app prototype. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth with self-reported insomnia symptoms, aged 13-18.
Key inclusion criteria (2 listed)
- 13-18 years old
- Self-reported insomnia symptoms
Key exclusion criteria (1 listed)
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Firefly Mobile App: A Digital Health Solution for Healthy Sleep in TeensA six week cognitive behavioral therapy for insomnia program delivered via a mobile app. | Behavioural | Beta Cohort 2, Teen Advisory Board (TAB)/Beta Cohort 1 |
Primary outcome
Program Completion Percentage
Time frame: Immediately post-treatment
1 secondary outcome
Treatment Acceptability Ratings
Time frame: Immediately post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Adolescent, run by University of Kansas Medical Center 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Apr 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Completion Percentage (time frame: Immediately post-treatment). 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 14 Apr 2026.