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Study identifier: NCT04949360 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

SleepUp Digital CBTi-based Platform for Insomnia

Condition: Insomnia · Sleep Disorder · Sleep Hygiene  ·  Sponsor: SleepUp Tecnologia em Saúde Ltda

PhaseNA
Planned participants280
Who can joinAll sexes, 20 Years to 60 Years
Healthy volunteersNo

About this study

Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases. Phase 1 The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups: * Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists). * Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral * Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform. * Online CBTi + additional features (CBTi-O+): This …

This description comes directly from the study's public registry record.

Talk to the study team

Pesquisa SleepUp  ·  +55 11 93319-1375  ·  pesquisa@sleepup.com.br

Gabriel N. Pires, PhD  ·  +55 11 933191375  ·  pesquisa@sleepup.com.br

Always discuss trial participation with your own doctor first.

Locations (1)

SleepUp Tecnologia em Saúde LTDASão Caetano do Sul, São Paulo, BrazilRecruiting

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Source record: clinicaltrials.gov/study/NCT04949360