Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study tests App-Based therapy to help millions quit sleeping pills safely

NCT ID NCT06435520

Symptom relief Sponsor: National Jewish Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a digital cognitive behavioral therapy app (Sleepio) combined with a doctor-supervised medication tapering plan can help people stop using sleeping pills. Researchers will recruit 430 adults from primary care clinics who have used sleep aids for over 6 months. The goal is to see if the combined approach works better than tapering alone for reducing pill use and improving sleep.

What this could mean

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

Active substance
Digital cognitive behavioral therapy (Sleepio app) and structured medication tapering
What this could lead to
If successful, this could offer a practical, non-drug way for millions to safely stop relying on sleeping pills, reducing health risks like falls and memory problems.
What could go wrong
This is a Phase 4 trial, but it's still early for real-world use. The digital therapy may not work for everyone, and tapering can be difficult. Results depend on patient motivation and clinic support.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 430 people

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

Started

Jan 2025

Expected to finish

Jun 2029

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

21 years and older

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: * a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications; * a desire to decrease/eliminate hypnotic use; * a history of insomnia that meets DSM-560 criteria for insomnia disorder; and * willingness to provide written informed consent to participate. Exclusion Criteria: * a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder; * presence of an unstable, untreated, or terminal major medical or psychiatric disorder; * alcohol or drug abuse within the past year; * current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder); * pregnancy; * significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE); * current use of medications known to cause insomnia (e.g., high dose corticosteroids); * untreated comorbid sleep disorders; * use of a sedating antidepressant or antipsychotic medication solely for sleep; and * consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hypnotic dependence are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

Hypnotic dependence 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

  • National Jewish Health

    RECRUITING

    Denver, Colorado, 80206, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.