Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT04258618
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-85 years old
* Patients starting rTMS treatment for MDD
* Co-morbid insomnia as determined by meeting the following criteria: (a) Requiring more than 30 minutes to fall asleep at the beginning of the night or more than 30 minutes of time awake after initially falling asleep for at least 3 nights per week for at least 3 months - - An insomnia severity index score of 15 or more
* Manifested sleep disturbances or associated daytime symptoms causing significant distress or impairment in social, occupational or other areas of functioning
* Reliable access to a computer with internet access.
Exclusion Criteria:
* Obligation to an irregular sleep schedule that prevents the adoption of intervention strategies such as shift workers
* Participants who have received or are receiving CBT-I targeting insomnia in the past, or those who have initiated a new sedative medication, or sedating antidepressant within 2-weeks preceding enrollment
* Comorbid psychiatric disorders, including bipolar disorder, psychotic disorders or depression with psychotic features
* Presence of another untreated sleep disorder such as obstructive sleep apne
* Pregnancy
* Active substance use disorder within the past 3 months
* Use of medications that reduce the seizure threshold including Buproprion, stimulants or augmenting thyroid medications (for those without history of hypothyroid)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04258618
Study Brief:
Protocol Section:
NCT04258618