An observational study in Narcolepsy, Narcolepsy 1 and Narcolepsy Type 1, sponsored by University of Dublin, Trinity College. Suspended at 1 site in Ireland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-06-05.
Sponsored by University of Dublin, Trinity College · Observational
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.
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.
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.
Exclusion Criteria:
Other: Assessment of physical performance variables
Other: Assessment of physical performance indices using the following outcome measures: Cardiopulmonary fitness: YMCA submaximal bike test Upper Body: ACSM press up test, Dynamometry Lower body: Wall squat test, Countermovement jump test
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
The submaximal Young Men's Christian Association (YMCA) exercise test utilises the relationship between workload and heart rate to predict maximal oxygen consumption. Provides indication of cardiopulmonary fitness.
Time frame: 30 minutes
Measurement of grip strength
Objective measure of grip strength of the dominant and non-dominant hands, and will provided indication of how grip strength compares to age and gender-matched norms. Dynamometry will be used to asses muscle strength of the upper limb.
Time frame: 15 minutes
Measurement of upper limb endurance
The American College of Sports Medicine Press Up Test will be used to objectively measure muscular endurance of the upper limb. Identifies the maximum number of press ups that the participant can perform before failure.
Time frame: 10 minutes
Measurement of lower limb endurance
The wall sit test will be used to objectively measure lower limb endurance. Measures the duration a participant can maintain a wall sit until failure.
Time frame: 10 minutes
Measurement of lower limb power.
The Countermovement Jump Test will be used to objectively measure lower limb power. This test measures both jump height and peak power achieved by participants.
Time frame: 10 minutes
Measurement of physical activity
Actigraphy will be used to objectively measure physical activity and sedentary behaviour. Participant will be required to wear the actigraph around their waist during all waking hours except during swimming or bathing, and then send back to assessor in return-addressed envelopes.
Time frame: 7 days
Subjective measure of Health-Related Quality of Life
Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).
Time frame: 10 minutes
Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)
Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires
Time frame: 10 minutes
Subjective measure of symptom severity
Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.
Time frame: 10 minutes
Subjective measure of daytime sleepiness
Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.
Time frame: 5 minutes
Subjective measure of physical activity
Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.
Time frame: 5 minutes
Subjective measure of sedentary behaviour
Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.
Time frame: 5 minutes
Plan to share: Yes — In keeping with the research policy of Trinity College Dublin, relevant and anonymised data and materials will be made available through Trinity College's Access to Research Archive (TARA) data depository.
Supporting information: Study protocol
No publications or documents are linked to this record.
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University of Dublin, Trinity College