'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'

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.

Study Overview

• Status: Suspended
• Conditions: Narcolepsy; Hypersomnolence; Narcolepsy Type 1; Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy; Narcolepsy 1; Narcolepsy and Hypersomnia
• Intervention / Treatment: Other: Assessment of physical performance variables

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.

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D08 W9RT
    • Department of Physiotherapy, School of Medicine, Trinity College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Narcolepsy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective measure of Health-Related Quality of Life	Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).	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	10 minutes
Subjective measure of symptom severity	Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.	10 minutes
Subjective measure of daytime sleepiness	Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.	5 minutes
Subjective measure of physical activity	Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.	5 minutes
Subjective measure of sedentary behaviour	Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.	5 minutes

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Collaborators: St. James's Hospital, Ireland

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ANTICIPATED): May 31, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (ACTUAL): June 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Physical activity; Muscle strength; Physical performance; Muscle endurance; Cardiopulmonary fitness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy; Cataplexy
• Other Study ID Numbers: Cross sectional

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No