Clinical trial NCT04419792: 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Official title: 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Narcolepsy
Narcolepsy 1
Narcolepsy Type 1
Narcolepsy With Cataplexy
Narcolepsy Without Cataplexy
Narcolepsy and Hypersomnia
Hypersomnolence
Keywords: Physical performance
Cardiopulmonary fitness
Muscle strength
Muscle endurance
Quality of life
Physical activity
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
Collaborators: name: St. James's Hospital, Ireland
First posted: 2020-06-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The following eligibility criteria: Aged 18 to 65 years, diagnosis of type 1 or type 2 narcolepsy based on the International Classification of Sleep Disorders third edition criteria for at least six months, eligibility screened by their treating clinician, and able to understand English and follow simple instruction to enable completion of assessments. Additionally, participants will be required to provide signed and informed consent to participate in the study, and for processing of their data to be eligible for participation. Individuals with sleep disorders other than narcolepsy, contraindications to moderate-intensity exercise, confirmed pregnancy or significant psychiatric illness or cognitive impairment will be excluded from participating in the study.

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 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.

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 cardiopulmonary fitness, physical activity, and muscle strength and endurance of this population.

Secondary objectives of this study will be to explore the relationship between physical performance indices and sleep quality, functional ability and quality of life in this population.

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.

Primary outcomes:
measure: Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
timeFrame: 30 minutes
measure: Measurement of grip strength
timeFrame: 15 minutes
measure: Measurement of upper limb endurance
timeFrame: 10 minutes
measure: Measurement of lower limb endurance
timeFrame: 10 minutes
measure: Measurement of lower limb power.
timeFrame: 10 minutes
measure: Measurement of physical activity
timeFrame: 7 days
Secondary outcomes:
measure: Subjective measure of Health-Related Quality of Life
timeFrame: 10 minutes
measure: Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)
timeFrame: 10 minutes
measure: Subjective measure of symptom severity
timeFrame: 10 minutes
measure: Subjective measure of daytime sleepiness
timeFrame: 5 minutes
measure: Subjective measure of physical activity
timeFrame: 5 minutes
measure: Subjective measure of sedentary behaviour
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Department of Physiotherapy, School of Medicine, Trinity College Dublin
Study officials:
References: