Trials / Active Not Recruiting
Active Not RecruitingNCT06109051
EndeavorOTC™ Prospective Product Registry
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 198 (actual)
- Sponsor
- Akili Interactive Labs, Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
Summary
The EndeavorOTC product registry aims to collect real world data from EndeavorOTC users. The objectives of this registry are to describe clinical and demographic characteristics, treatment patterns, clinical and quality of life outcomes, and healthcare utilization in EndeavorOTC users in a real-world setting.
Detailed description
All EndeavorOTC users who subscribe to EndeavorOTC are invited to participate in this product registry. Users must provide their informed consent and have an active subscription to the product at time of enrollment to participate. Study activities are emailed to participants at baseline, 1, 2, 3, 6, 9, and 12-months after enrollment. Study activities consist of an online survey and online ADHD assessment. All data are captured electronically and securely through commercial data capture platforms.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EndeavorOTC | EndeavorOTC™ is an over-the-counter digital therapeutic designed to improve attention function, ADHD symptoms, and quality of life in users 18 years of age and older with primarily inattentive or combined-type ADHD, who have been identified as having a significant attentional impairment. EndeavorOTC utilizes the same proprietary technology underlying EndeavorRx, a prescription digital therapeutic indicated to improve attention function in children ages 8-12. EndeavorOTC is not intended to be a replacement for any form of ongoing treatment. EndeavorOTC is deployed on mobile devices and incorporates adaptive, simultaneous cognitive tasks in a consumer-grade action videogame-based platform with high-quality graphics and reward mechanisms. |
Timeline
- Start date
- 2023-10-03
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2023-10-31
- Last updated
- 2024-06-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06109051. Inclusion in this directory is not an endorsement.