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Can a smartphone app cure insomnia in teens? new trial aims to find out

NCT ID NCT07405775

Symptom relief Sponsor: Woolcock Institute of Medical Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This pilot study tests whether a smartphone app called SleepFix, combined with support from a psychologist, can help young people aged 16-24 with insomnia. The app uses sleep restriction therapy to reset sleep patterns. The trial will check if the approach is practical and acceptable, and measure changes in sleep quality, fatigue, and mood. Results will guide a larger study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SleepFix mobile app (sleep restriction therapy) plus e-psychologist support calls
What this could lead to
If successful, this could provide an accessible, app-based treatment option for young people with insomnia, reducing symptoms and improving sleep quality.
What could go wrong
This is a small pilot study (40 participants) testing feasibility, not effectiveness. The intervention requires consistent app use and may not work for everyone. Results are preliminary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 24 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 16 -24 years old * Able to give informed online consent and if younger \<18years old guardian/parental consent * Insomnia Severity Index ≥ 10 * English fluency * Access to a smartphone and willingness to use a mobile app for healthcare Exclusion Criteria: * Shift-workers with regular shifts between the hours of 8pm and 8am. * Recent travel to a destination with \>2 hours time difference (within last 7-days and with subjective reports that they are not experiencing jet lag). * Serious medical and/or psychiatric illnesses/disorders (e.g., Epilepsy or other seizure disorders, heart failure, bipolar disorder, schizophrenia, Major Depressive disorder) * Self-reported/diagnosed sleep disorders other than insomnia (e.g. - Obstructive Sleep Apnoea, REM/NREM sleep disorders, Restless Leg Syndrome, Narcolepsy, free running cycle \& Circadian rhythm disorder) * Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT). * Pregnant * Professional driver or operate heavy machinery

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Woolcock Institute of Medical Research

    RECRUITING

    Sydney, New South Wales, 2113, Australia

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