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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT04299100
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria are:
* Adult patients (≥18 years old) with cognitive capability
* Diagnosed with chronic non-cancer pain for \> 3 months
* Reports sleep disturbances such as difficulty falling asleep, staying asleep, or problems waking up too early (responds "Mild", "Moderate", "Severe", or "Very Severe" to items 1, 2, or 3 on the Insomnia Severity Index).
Exclusion Criteria:
* Patients with chronic pain secondary to a neoplasm or metastasis
* Conditions potentially interfering with comprehension and delivery of informed consent, such as certain neurological or psychiatric disorders
* Patients with severe insomnia (Insomnia Severity Index ≥ 22)
* Restless legs syndrome
* Periodic limb movement disorder
* Sleep apnea
* Narcolepsy
* Seizure disorder
* Patients who are pregnant
* Currently undergoing a psychological treatment for insomnia
* Participants who require an urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines (e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, pulmonary hypertension, hypercapnia respiratory failure).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04299100
Study Brief:
Protocol Section:
NCT04299100