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:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2025-12-24 @ 12:23 PM
NCT ID:
NCT06264661
Eligibility Criteria:
Inclusion Criteria:
Have a medical record in the Endocrinology service at the Hospital Juarez de Mexico
* Patients with type 2 diabetes mellitus
* Age between 40 and 60 years
* Present Insomnia based on the criteria of The Diagnostic and Diagnostic Manual Statistics of Mental Disorders (DSM-V) which defines insomnia such as predominant dissatisfaction with the quantity or quality of sleep, associated with one (or more) of the following symptoms: a) Difficulty starting the dream,or b) Difficulty maintaining sleep, characterized by awakenings frequent and c) Waking up early in the morning with inability to return to sleep; with clinically significant distress or social impairment, work, educational, academic, behavioral or other important areas of operation, at least three nights a week, for a minimum of three months even with favorable sleeping conditions.
* Sign an informed consent letter and agree to participate in the study.
* Accept taking a blood sample pre and post intervention
* HbA1c level above 6.1% (120 mg/dL;7 mmol/L) or BMI less than 34.9 units
Exclusion Criteria:
* Do not agree to sign the informed consent
* Have a previous psychiatric diagnosis
* Have neurological disorders
* Be diagnosed with type 1 diabetes mellitus or BMI greater than 35 units
* Missing more than 20% of the sessions (2 sessions)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
60 Years
Study:
NCT06264661
Study Brief:
Protocol Section:
NCT06264661