NarcolepsyNCT04419792
'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
An observational study of Narcolepsy and Narcolepsy 1, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy, Narcolepsy 1, Narcolepsy Type 1
- What is being tested?
- Assessment of physical performance variables
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 15 Oct 2019to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Department of Physiotherapy, School of Medicine, Trinity College Dublin
Dublin, D08 W9RT
About this study
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.
Read the 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.
- Conditions
- Narcolepsy, Narcolepsy 1, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy, Narcolepsy and Hypersomnia
- Being tested
- Assessment of physical performance variables
- Keywords
- Physical performance, Cardiopulmonary fitness, Muscle strength, Muscle endurance, Quality of life, Physical activity
- Medical subject headings
- Narcolepsy, Narcolepsy 1, Disorders of Excessive Somnolence, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of physical performance variablesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Narcolepsy | Not described Receives: Other: Assessment of physical performance variables |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Secondary outcomes (6)
Subjective measure of Health-Related Quality of Life
Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).
Measured: 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
Measured: 10 minutes
Subjective measure of symptom severity
Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.
Measured: 10 minutes
Subjective measure of daytime sleepiness
Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.
Measured: 5 minutes
Subjective measure of physical activity
Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.
Measured: 5 minutes
Subjective measure of sedentary behaviour
Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Oct 2019
- Primary completion31 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Why it stopped: Recruitment for study has been suspended due to Covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Responsible party
- Principal investigator, Ragy Tadrous, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419792
- Sponsor's protocol ID
- Cross Sectional
- Status last verified
- Jun 2020
- First submitted
- 12 May 2020
- Last updated
- 5 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
- ClinicalTrials.gov ID
- NCT04419792
- Acronym / sponsor ID
- Cross Sectional
- Conditions
- Narcolepsy, Narcolepsy 1, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy, Narcolepsy and Hypersomnia
- Keywords
- Physical performance, Cardiopulmonary fitness, Muscle strength, Muscle endurance, Quality of life, Physical activity
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Recruitment for study has been suspended due to Covid-19.
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- St. James's Hospital, Ireland
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Narcolepsy | – | Other: Assessment of physical performance variables |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of physical performance variablesOther: 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 | Other | Narcolepsy |
Primary outcome
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
Time frame: 30 minutes
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.
Measurement of grip strength
Time frame: 15 minutes
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.
Measurement of upper limb endurance
Time frame: 10 minutes
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.
Measurement of lower limb endurance
Time frame: 10 minutes
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.
Measurement of lower limb power.
Time frame: 10 minutes
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.
Measurement of physical activity
Time frame: 7 days
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.
6 secondary outcomes
Subjective measure of Health-Related Quality of Life
Time frame: 10 minutes
Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)
Time frame: 10 minutes
Subjective measure of symptom severity
Time frame: 10 minutes
Subjective measure of daytime sleepiness
Time frame: 5 minutes
Subjective measure of physical activity
Time frame: 5 minutes
Subjective measure of sedentary behaviour
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Individual participant dataSharing planned: 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.
Related trials for Narcolepsy
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Narcolepsy and Narcolepsy 1, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted) (time frame: 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.