NCT04949360 SleepUp Digital CBTi-based Platform for Insomnia
| NCT ID | NCT04949360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SleepUp Tecnologia em Saúde Ltda |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2025-11-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2025-05-19 with a primary completion date of 2025-11-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth. All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group. Phase 2 This phase will comprise 120 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 three groups: * 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 group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth. All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.
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.
Contact & Investigator
Gabriel N. Pires, PhD
PRINCIPAL INVESTIGATOR
Universidade Federal de São Paulo
Frequently Asked Questions
Who can join the NCT04949360 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 60 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04949360 currently recruiting?
Yes, NCT04949360 is actively recruiting participants. Contact the research team at pesquisa@sleepup.com.br for enrollment information.
Where is the NCT04949360 trial being conducted?
This trial is being conducted at São Caetano do Sul, Brazil.
Who is sponsoring the NCT04949360 clinical trial?
NCT04949360 is sponsored by SleepUp Tecnologia em Saúde Ltda. The principal investigator is Gabriel N. Pires, PhD at Universidade Federal de São Paulo. The trial plans to enroll 280 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.