Status:
SUSPENDED
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Lead Sponsor:
University of Dublin, Trinity College
Collaborating Sponsors:
St. James's Hospital, Ireland
Conditions:
Narcolepsy
Narcolepsy 1
Eligibility:
All Genders
18-65 years
Brief 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 a...
Detailed Description
This study aims to profile the physical functioning variables of people with narcolepsy attending an outpatient clinic at St. James's Hospital. This will be accomplished by ascertaining the cardiopulm...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
October 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04419792
Start Date
October 15 2019
End Date
September 30 2020
Last Update
June 5 2020
Active Locations (1)
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1
Department of Physiotherapy, School of Medicine, Trinity College Dublin
Dublin, Ireland, D08 W9RT