'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy' (NCT04419792) | Clinical Trial Compass
SuspendedNot Applicable
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Stopped: Recruitment for study has been suspended due to Covid-19.
Ireland70 participantsStarted 2019-10-15
Plain-language summary
Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness and significantly impacts quality of life. People with narcolepsy demonstrate many potential barriers to being physically active, such as sleepiness and social isolation. Very little is known about how physical performance variables may be affected and influence disease experience in people with narcolepsy. This study aims to profile the physical fitness and physical functioning variables of adults with narcolepsy and to explore the relationship between physical variables, quality of life, symptom severity and disease experience in this cohort.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. 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.
✓. Able to understand English - as questionnaires will necessitate a sufficient level of English for completion.
Exclusion criteria
✕. 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.
What they're measuring
1
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
✕. 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.
✕. 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.
✕. Dementia or significant cognitive impairment or psychiatric illness that would preclude ability to participate in study.