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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT04419792
Eligibility Criteria:
Inclusion Criteria:
1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International Classification of Sleep Disorders, third edition (ICSD-3) criteria for at least 6 months - diagnosis for at least 6 months will ensure that initial fluctuations due to likely starting on new drug regimen are relatively stable.
2. Eligibility screened and agreement of the participant's treating clinician in Narcolepsy out-patient clinic of St. James's Hospital that he/she can participate - to ensure that as per General Data Protection Regulation guidelines that the treating clinician eligibility screens rather than the physiotherapy study researcher.
3. Patients aged ≥18 to \<65 years at the time of obtaining informed consent - as patients \>18 years will not been seen in this centre, and patients \>65 years may have age-related changes in cardiovascular fitness and physical activity which may be difficult to separate from those pertaining to narcolepsy diagnosis.
4. Able to understand English - as questionnaires will necessitate a sufficient level of English for completion.
Exclusion Criteria:
1. Patients with sleep disorders other than narcolepsy (e.g., moderate to severe sleep apnea syndrome, moderate to severe periodic limb movement disorder) - so results are not diluted by including conditions other than narcolepsy.
2. Any medical contraindication to exercise of moderate intensity and short duration including but not limited to cardiovascular or respiratory conditions, morbid obesity, and severe osteoarthritis of the lower extremities - as these conditions would preclude ability to conduct physical test battery.
3. Confirmed pregnancy - people with an advanced pregnancy may score differently on physical functioning/performance tests, people with a confirmed pregnancy will be excluded from study participation to limit bias.
4. Dementia or significant cognitive impairment or psychiatric illness that would preclude ability to participate in study.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04419792
Study Brief:
Protocol Section:
NCT04419792