Chronic Insomnia Clinical Trial
Official title:
Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia
The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.
This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03171519 -
Effects of Exercise and Acupuncture on Chronic Insomnia
|
N/A | |
| Completed |
NCT02515006 -
Impact of Homeopathy for Persistent Insomnia in Patients With Cancer
|
N/A | |
| Recruiting |
NCT05247697 -
Mirtazapine for Chronic Insomnia in Older Adults
|
Phase 1 | |
| Active, not recruiting |
NCT04350866 -
Enhancing Access to Insomnia Care in VA PCMHI Clinics
|
||
| Active, not recruiting |
NCT04366284 -
Optimizing the Scalability of Evidence-Based Behavioral Sleep Medicine Practices With a Digital Health Platform
|
N/A | |
| Recruiting |
NCT04761796 -
Sleep Time and Insomnia Factors Among Professional Flight Members
|
||
| Completed |
NCT02688569 -
Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study
|
N/A | |
| Completed |
NCT02236845 -
Pilot Study to Clinical Evaluate Lacrima Medical Device in Insomnia Patients
|
N/A | |
| Completed |
NCT01949389 -
Piloting an Internet-based Therapy for Insomnia in a Population of Veterans With Substance Use Disorders
|
N/A | |
| Completed |
NCT00414102 -
Subjective Efficacy of Ramelteon on Sleep in Adults With Chronic Insomnia.
|
Phase 4 | |
| Completed |
NCT00671294 -
Safety and Efficacy of Ramelteon in Elderly Subjects With Chronic Insomnia.
|
Phase 3 | |
| Completed |
NCT02392000 -
Mobile Sleep Intervention for OEF, OIF and OND Veterans
|
N/A | |
| Recruiting |
NCT04471168 -
Interest of Auriculotherapy in the Management of Chronic Insomnia
|
N/A | |
| Completed |
NCT02774642 -
Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
|
N/A | |
| Completed |
NCT02290405 -
Impact of Hyperarousal on Simple and Complex Cognitive Task Performance Among Insomnia Sufferers
|
||
| Recruiting |
NCT05618002 -
Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients
|
||
| Completed |
NCT01995838 -
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Bayesian Adaptive Randomization Design, Dose Response Study of the Efficacy of E2006 in Adults and Elderly Subjects With Chronic Insomnia
|
Phase 2 | |
| Active, not recruiting |
NCT02272712 -
The Effectiveness of Online Treatment for Insomnia in Cancer Survivors
|
N/A | |
| Completed |
NCT00915135 -
Efficacy and Safety of Ramelteon on Chronic Insomnia
|
Phase 2 | |
| Completed |
NCT04635098 -
DexmedetOmidine Complement Treats Chronic insOmnia and Improves Circadian Rhythm (DOCTOR)
|
N/A |