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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT02232256
Eligibility Criteria:
Inclusion Criteria:
* Age \> 17 and \< 75
* Chronic non-cancer pain (CNCP) associated with a complaint of poor sleep. Validated tool the Pittsburgh Sleep Quality Index (PSQI) for sleep dysfunction and using a suitable cut points (PSQI \>/=5) to ensure greater homogeneity of the sample and the recruitment of only those with significant pain related sleep disturbance.
* Stable pain management therapy for 1 month prior to entry into the study
* Having a confirmed diagnosis of CNCP for greater than 1 year
* Written informed consent obtained.
* Subject agreed to follow the protocol.
Exclusion Criteria:
* Taking a hypnotic medication at time of enrollment. Patients may be enrolled if they are willing to cease any current hypnotic for at least 2 weeks prior to commencing the study
* Current alcohol abuse or other addiction
* Sleep apnea disorder
* Inability to understand and comply with the instructions of the study
* Previous enrollment in the study
* Renal and/or liver insufficiency
* Patients less than age 18
* Pregnancy or lactation
* Current (\</=one year) DSM-IV Axis I diagnosis of major depressive disorder, dysthymia, generalized anxiety disorder and DSM-IV diagnosis of mania, bipolar disorder, or psychosis determined either by patient history
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02232256
Study Brief:
Protocol Section:
NCT02232256