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Search / Trial NCT04949360

SleepUp Digital CBTi-based Platform for Insomnia

Launched by SLEEPUP TECNOLOGIA EM SAÚDE LTDA · Jun 24, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Insomnia Sleep Cognitive Behavioral Therapy Cb Ti

ClinConnect Summary

This clinical trial is studying the effectiveness of a digital platform called SleepUp, which is designed to help people with insomnia through a method known as Cognitive-Behavioral Therapy for insomnia (CBTi). The trial involves 160 participants aged 20 to 60 who experience at least mild insomnia symptoms. Participants will be randomly placed into one of four groups: one will receive standard remote therapy sessions with sleep psychologists, another will get basic information about sleep hygiene, a third will use the SleepUp app for eight weeks of CBTi treatment, and the fourth will enjoy the full version of the app with additional features like meditation and relaxation tools.

To be eligible for this trial, participants must speak Brazilian Portuguese, have insomnia symptoms, and own an Android smartphone or tablet with internet access. Those who have previously used CBTi, taken sleeping pills regularly in the last three months, or have certain health conditions will not be included. Throughout the eight weeks, all participants will complete questionnaires to track their sleep progress, with follow-up assessments occurring two, four, and six months after the treatment ends. This study will help determine how effective digital therapy can be in treating insomnia, potentially offering new solutions for those struggling to sleep.

Gender

ALL

Eligibility 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.

About Sleepup Tecnologia Em Saúde Ltda

SleepUp Tecnologia em Saúde LTDA is a pioneering clinical trial sponsor dedicated to advancing innovations in sleep health and technology. With a focus on developing evidence-based solutions, the company conducts rigorous clinical research to evaluate novel therapies and interventions aimed at improving sleep quality and addressing sleep disorders. By leveraging cutting-edge technology and a multidisciplinary approach, SleepUp aims to contribute significantly to the field of sleep medicine, enhancing patient outcomes and promoting overall well-being.

Locations

São Caetano Do Sul, São Paulo, Brazil

São Caetano Do Sul, , Brazil

Patients applied

0 patients applied

Trial Officials

Gabriel N. Pires, PhD

Principal Investigator

Universidade Federal de São Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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