Digital platform for treating insomnia with cognitive-behavioral therapy
Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
NA · SleepUp Tecnologia em Saúde Ltda · NCT04949360
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | SleepUp Tecnologia em Saúde Ltda (industry) |
| Locations | 1 site (São Caetano do Sul, São Paulo) |
| Trial ID | NCT04949360 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are literate Brazilian Portuguese speakers aged 20 to 60 with mild insomnia symptoms.
Not a fit: Patients with prior experience in CBTi or those using sleeping pills frequently may not benefit from this study.
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 performed: Previous studies have shown that CBTi is effective for insomnia, but the digital platform approach is relatively novel.
Eligibility criteria
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 this trial is running
São Caetano do Sul, São Paulo
- SleepUp Tecnologia em Saúde LTDA — São Caetano do Sul, São Paulo, Brazil (RECRUITING)
Study contacts
- Principal investigator: Gabriel N. Pires, PhD — Universidade Federal de São Paulo
- Study coordinator: Pesquisa SleepUp
- Email: pesquisa@sleepup.com.br
- Phone: +55 11 93319-1375
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Sleep Disorder, Sleep Hygiene, Sleep, Cognitive-behavioral therapy, CBTi