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Long-term Follow-up of RESTORE Study

NCT05647785 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2022-12-12

No results posted yet for this study

Summary

The RESTORE extension study is a non-interventional, long-term follow-up study with people who participated in the study referred to as RESTORE (NCT05227898).

The purpose of this extension study is to understand the durability of the effects of two digital software devices on anxiety and other indicators of psychological and physical health in participants of the RESTORE study in the 6-months after study completion.

Subjects who were enrolled and not withdrawn from the original RESTORE study are eligible to participate. People who consent to participate will be asked to electronically complete a set of questionnaires at 3 months and 6 months following the scheduled date of their RESTORE end-of-study visit.

Conditions

Interventions

DEVICE

Long-term follow-up of cerena™

Long term follow-up for eligible participants from the RESTORE study

DEVICE

Long-term follow-up of attune™

Long term follow-up for eligible participants from the RESTORE study

Sponsors & Collaborators

  • Blue Note Therapeutics

    lead INDUSTRY

Principal Investigators

  • Dianne M Shumay, PhD · Blue Note Therapeutics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2023-05-31
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647785 on ClinicalTrials.gov