Clinical trial Recruiting at 1 site Interventional Ages 20 to 60

Digital platform for treating insomnia with cognitive-behavioral therapy

Official title: Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia

Run by SleepUp Tecnologia em Saúde Ltda · NCT04949360 · Data updated 2026-11-12

This study is testing a digital program that uses therapy to help people aged 20 to 60 with mild insomnia sleep better compared to traditional treatments.

Quick facts

Study typeInterventional
Ages20 Years to 60 Years
SexAll
Enrollment280 (estimated)
SponsorSleepUp Tecnologia em Saúde Ltda
Industry-sponsored
Locations1 site (São Caetano do Sul, São Paulo)
StatusRecruiting
StartedMay 19, 2025
Main results expectedNovember 18, 2025
Study endsDecember 1, 2026
Registry record updatedDecember 29, 2025
Trial IDNCT04949360 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are literate Brazilian Portuguese speakers aged 20 to 60 with mild insomnia symptoms.

Probably not a fit

Patients with prior experience in CBTi or those using sleeping pills frequently may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the SleepUp digital platform, which utilizes Cognitive-Behavioral Therapy for insomnia (CBTi) to help individuals reduce their insomnia symptoms. Participants aged 20 to 60 with mild insomnia will be randomized into four groups, including a standard CBTi treatment with board-certified psychologists and a minimal intervention focusing on sleep hygiene. The study aims to determine if the digital approach can effectively alleviate insomnia symptoms compared to traditional methods. Recruitment will occur through social media advertisements, and participants will be monitored throughout the eight-week treatment period.

Why it matters

Potential benefit: If successful, this platform could provide an accessible and effective treatment option for individuals suffering from insomnia.

How similar studies have gone: Previous studies have shown that CBTi is effective for insomnia, but the digital platform approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Literate Brazilian portuguese speakers.
* Insomnia symptoms (as measured by ISI).
* An Android-based smartphone or tablet with access to the Internet.

Exclusion Criteria:

* Previous experience with CBTi.
* Use of sleeping pills or any other treatment for insomnia for two or more days a week in the last three months.

Where it's running

  • SleepUp Tecnologia em Saúde LTDA
    São Caetano do Sul, São Paulo, Brazil
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.