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SleepUp Digital CBTi-based Platform for Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04949360
Recruitment Status : Not yet recruiting
First Posted : July 2, 2021
Last Update Posted : September 17, 2021
Sponsor:
Information provided by (Responsible Party):
SleepUp Tecnologia em Saúde Ltda

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.

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 informative material regarding normal sleep pattern and sleep hygiene (through regular mail and e-mail). 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): This group will receive access to an eight-month 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, the sleep log and the clinical tests 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. The treatment last eight weeks.
  • 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. Additionally, follow ups will be made at two, four and six months after the end of the intervention. Equivalent intervals will be applied to the SH-MI group.


Condition or disease Intervention/treatment Phase
Insomnia Sleep Disorder Sleep Hygiene Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies Behavioral: Regular Cognitive Behavioural Therapy for Insomnia Behavioral: Sleep hygiene - minimal intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized and distributed in four parallel and independent groups.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Evaluation of SleepUp Digital CBTi-based Platform in the Treatment of Insomnia
Estimated Study Start Date : November 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arm Intervention/treatment
Active Comparator: Standard CBTi (CBTi-S):
This 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. Due to the restriction imposed by the COVID-19 pandemic, the appointments will be made remotely (video calls with psychologists), which have already been proven to be equivalent to the in-person CBTi.
Behavioral: Regular Cognitive Behavioural Therapy for Insomnia
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.

Placebo Comparator: Minimal intervention - Sleep hygiene (MI-SH):
This 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 regular mail and e-mail). 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.
Behavioral: Sleep hygiene - minimal intervention
It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by regular mail and email.

Experimental: Online CBTI (CBTI-O)
This group will receive access to an eight-month 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, the sleep log and the clinical tests 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. The treatment last eight weeks.
Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies
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.

Experimental: 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.
Behavioral: Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies
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.




Primary Outcome Measures :
  1. Adherence to the treatment [ Time Frame: On the completion of the intervention (average: 8 weeks) ]
    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 (SL-MI).

  2. Response to treatment [ Time Frame: On the baseline and on the completion of the intervention (average: 8 weeks) ]
    Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.

  3. Remission of symptoms [ Time Frame: On the completion of the intervention (average: 8 weeks) ]
    Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.

  4. Maintenance of results [ Time Frame: 6 months after the end of the treatment. ]
    Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of "response to treatment" and "remission of symptoms".


Secondary Outcome Measures :
  1. Adherence to the treatment [ Time Frame: 2 weeks after the beginning of the intervention. ]
    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 (SL-MI).

  2. Adherence to the treatment [ Time Frame: 4 weeks after the beginning of the intervention. ]
    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 (SL-MI).

  3. Adherence to the treatment [ Time Frame: 6 weeks after the beginning of the intervention. ]
    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 (SL-MI).

  4. Response to treatment [ Time Frame: On the baseline and 2 weeks after the beginning of the intervention. ]
    Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.

  5. Response to treatment [ Time Frame: On the baseline and 4 weeks after the beginning of the intervention. ]
    Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.

  6. Response to treatment [ Time Frame: On the baseline and 6 weeks after the beginning of the intervention. ]
    Patients are considered to be responsive to treatment if the ISI score is at least 7 points lower than on the basal evaluation.

  7. Remission of symptoms [ Time Frame: 2 weeks after the beginning of the intervention. ]
    Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.

  8. Remission of symptoms [ Time Frame: 4 weeks after the beginning of the intervention. ]
    Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.

  9. Remission of symptoms [ Time Frame: 6 weeks after the beginning of the intervention. ]
    Patients are considered to be with no symptoms of insomnia if the ISI score is lower then 8.

  10. Maintenance of results [ Time Frame: 2 months after the end of the treatment. ]
    Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of "response to treatment" and "remission of symptoms".

  11. Maintenance of results [ Time Frame: 4 months after the end of the treatment. ]
    Among those patients who completed the treatment program, maintenance of results will be calculated based on the same metrics of "response to treatment" and "remission of symptoms".

  12. Sleep quality [ Time Frame: 2 weeks after the beginning of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  13. Sleep quality [ Time Frame: 4 weeks after the beginning of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  14. Sleep quality [ Time Frame: 6 weeks after the beginning of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  15. Sleep quality [ Time Frame: On the completion of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  16. Sleep quality [ Time Frame: 2 months after the end of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  17. Sleep quality [ Time Frame: 4 months after the end of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  18. Sleep quality [ Time Frame: 6 months after the end of the treatment ]
    Sleep quality will be measured by the Pittsburgh Sleep Quality Index

  19. Sleep hygiene [ Time Frame: 2 weeks after the beginning of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  20. Sleep hygiene [ Time Frame: 4 weeks after the beginning of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  21. Sleep hygiene [ Time Frame: 6 weeks after the beginning of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  22. Sleep hygiene [ Time Frame: On the completion of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  23. Sleep hygiene [ Time Frame: 2 months after the end of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  24. Sleep hygiene [ Time Frame: 4 months after the end of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  25. Sleep hygiene [ Time Frame: 6 months after the end of the treatment ]
    Sleep hygiene habits will be measured by the Sleep Hygiene Index

  26. Excessive daytime sleepiness [ Time Frame: 2 weeks after the beginning of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  27. Excessive daytime sleepiness [ Time Frame: 4 weeks after the beginning of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  28. Excessive daytime sleepiness [ Time Frame: 6 weeks after the beginning of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  29. Excessive daytime sleepiness [ Time Frame: On the completion of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  30. Excessive daytime sleepiness [ Time Frame: 2 months after the end of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  31. Excessive daytime sleepiness [ Time Frame: 4 months after the end of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale

  32. Excessive daytime sleepiness [ Time Frame: 6 months after the end of the treatment ]
    Excessive daytime sleepiness will be measured using the Epworth Sleepiness Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Presence of self-reported co-morbidities (hypertension, hyper/hypothyroidism, asthma, bronquitis or other respiratory diseases, rhinitis, epilepsy and other neurological diseases, any psychiatric disease other than depression and anxiety, diabetes) or sleep disoders other than insomnia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949360


Contacts
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Contact: Renata Bonaldi, PhD +55 11 933191375 pesquisa@sleepup.com.br
Contact: Renata Bonaldi, PhD +55 11 95555-6467 renata.bonaldi@sleepup.com.br

Locations
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Brazil
SleepUp Tecnologia em Saúde LTDA
São Caetano Do Sul, São Paulo, Brazil, 09530-250
Contact: Renata Bonaldi, PhD    +55 11 95555-6467    renata.bonaldi@sleepup.com.br   
Sponsors and Collaborators
SleepUp Tecnologia em Saúde Ltda
Investigators
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Principal Investigator: Gabriel Pires, PhD Instituto do Sono
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Responsible Party: SleepUp Tecnologia em Saúde Ltda
ClinicalTrials.gov Identifier: NCT04949360    
Other Study ID Numbers: SleepUp_#01
34113520.1.0000.5494 ( Other Identifier: Brazilian National Comission of Research Ethics )
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SleepUp Tecnologia em Saúde Ltda:
Insomnia
Sleep
Cognitive-behavioral therapy
CBTi
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations