SleepUp Digital CBTi-based Platform for Insomnia
Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
2 other identifiers
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2021
CompletedFirst Posted
Study publicly available on registry
July 2, 2021
CompletedStudy Start
First participant enrolled
May 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedDecember 29, 2025
December 1, 2025
6 months
June 13, 2021
December 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Adherence to the treatment
It will be measured as the percentage of participants who completed the treatment, out of those who effectively initiated it. Dropouts will be considered whenever a participants fail to comply with the tasks relative to each group for two consecutive weeks, or postpone the completion of these tasks for three times. These tasks refer to the responses to periodic questionnaires and to the completion of the CBTi or CBTi-O sessions (when applicable).The aim of this comparison is to evaluate whether the adherence rate in the CBTi-O and CBTi-O+ groups are similar to the standard treatment (CBTi-S) or higher than the minimal treatment (MI-SH).
From enrollment (baseline) to the end of treatment at 8 weeks
Response to treatment
Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.
From enrollment (baseline) to the end of treatment at 8 weeks
Remission of symptoms
Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.
From enrollment (baseline) to the end of treatment at 8 weeks
Secondary Outcomes (6)
Self-reported sleep efficiency
From enrollment (baseline) to the end of treatment at 8 weeks
Sleep hygiene
From enrollment (baseline) to the end of treatment at 8 weeks
Excessive daytime sleepiness
From enrollment (baseline) to the end of treatment at 8 weeks
Sleep quality
From enrollment (baseline) to the end of treatment at 8 weeks
Self-reported sleep latency
From enrollment (baseline) to the end of treatment at 8 weeks
- +1 more secondary outcomes
Study Arms (4)
Standard CBTi (CBTi-S):
ACTIVE COMPARATORThis is a positive control group/active comparator, in which standard CBTi (the golden standard behavioral treatment for insomnia) will be made available. This treatment consists of an eight-week treatment composed by weekly and structured appointments with a board-certified sleep psychologist. The professionals performing the CBTi sessions will not be part of the research team. The appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.
Minimal intervention - Sleep hygiene (MI-SH):
PLACEBO COMPARATORThis group corresponds to a negative control group/placebo comparator, subjected to minimal intervention. It is based on the delivery of informative material regarding normal sleep pattern and sleep hygiene (through SleepUp app). This procedure is more adequate as a control than the commonly used no-treatment or waiting list controls, due to the behavioral nature of insomnia.
Online CBTI (CBTI-O)
EXPERIMENTALThis group will receive access to an eight-week CBTi-based treatment through the SleepUp app. The platform will be updated into a non-commercial version, and all features other than the CBTi track will be removed. This way, 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+)
EXPERIMENTALThis 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.
Interventions
The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.
This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.
It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app.
Eligibility Criteria
You may qualify if:
- Literate Brazilian portuguese speakers.
- Insomnia symptoms (as measured by ISI).
- An Android-based smartphone or tablet with access to the Internet.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SleepUp Tecnologia em Saúde LTDA
São Caetano do Sul, São Paulo, 09530-250, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel N. Pires, PhD
Universidade Federal de São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The participants cannot be blinded considering the type of intervention being tested. The allocation codes will be concealed and only three members of the research team will have access to the codes and randomization table. All the outcomes will be either collected automatically (via software) or by hired professionals unaware of the objectives of this trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2021
First Posted
July 2, 2021
Study Start
May 19, 2025
Primary Completion
November 18, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
December 29, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
The dissemination of Individual Participant Data (IPD) from this study is strictly limited by restrictions on the release of intellectual property, concerns regarding participant privacy and confidentiality, and the absence of explicit consent for extensive data sharing. However, upon reasonable request and subject to approval by the study's principal investigator, anonymized datasets may be provided to qualified researchers. It is imperative that requests include a thorough research proposal and a rationale that substantiates the need for the resources in question.