Narcolepsy Type 1NARCOSPORTNCT05460052
Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
An observational study of Narcolepsy Type 1, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Narcolepsy Type 1
- What is being tested?
- Physical activity training program, Weekly phone call. and Personalized training plan.
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2022to 24 Nov 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with type 1 narcolepsy, sedentary, aged 18 to 65 years. The patients will be recruited from the active file of adult NT1 patients followed in the Sleep Center of the University Hospital of Lyon.
Who may be able to join
- Diagnosis of Narcolepsy type 1 according to International Classification of Sleep Disorders, 3rd edition (ICSD 3-2014) criteria
- Patients aged 18 to 65 years
- Patients beneficiaries of social security
- Signed consent to participate in the study
- Access to a video conferencing device (smartphone, tablet or computer)
Who cannot join
- - Patients with a high level of physical activity on the Ricci and Gagnon Questionnaire (score >35) and/or regular physical activity in clubs
- Treatments not stabilized for less than 3 months
- Cognitive disorders incompatible with the understanding and implementation of the program
- Medical contraindication to exercise training
- Patient working night shifts
- Unstable somatic or psychiatric pathology
Show all 11Show fewer
- Severe untreated obstructive sleep apnea syndrome (apnea/hypopnea index >30/h)
- Pregnancy in progress or breastfeeding
- Persons deprived of liberty by a judicial or administrative decision,
- Persons admitted to a health or social institution for purposes other than research
- Persons of full age who are subject to a legal protection measure or who are unable to express their consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service de médecine du sommeil et des maladies respiratoires
Lyon, 69004
About this study
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
Read the detailed description
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
Current management is based on sleep hygiene as well as wake-promoting and anti-cataplectic medications. However, many patients complain of residual sleepiness or cataplexy. In addition, most of the proposed treatments are accompanied by side effects and have little effect on the comorbidities associated with the disease. Therapeutic alternatives are therefore needed in the management of narcolepsy.
Regular Physical Activity (RPA) is recommended by the World Health Organization (WHO) and has been shown to improve anxiety disorders, obesity, metabolic disorders, cognitive functions, sleep and quality of life.
In NT1, patients have fewer opportunities to practice RPA because of daytime sleepiness as well as increased sleep needs. Some studies suggest that cardiorespiratory performances may be lower in NT1 patients than in healthy controls, and that a higher level of physical activity may be associated with lower sleepiness and better metabolic profile in NT1 children. However, no prospective study has evaluated the feasibility of an exercise training program in NT1 or the effect of regular physical activity on disease severity.
The main objective of the study is to evaluate the effect of a physical activity training program of 3 sessions per week for 6 weeks on the severity of narcolepsy in sedentary adults with NT1.
The secondary objectives are to evaluate the feasibility of this program in an adult NT1 population, the effect of the program on comorbidities (obesity, metabolic disorders, anxiety-depressive symptoms, cognitive disorders), medication dosage and quality of life, its tolerance, and the satisfaction of the patients at short- (6 weeks) and long-term (6 months).
- Conditions
- Narcolepsy Type 1
- Being tested
- Physical activity training program, Weekly phone call., Personalized training plan.
- Keywords
- Narcolepsy, Chronic neurological disorder, Regular physical activity
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity training programOther
The physical activity training program will consist of 3 sessions per week for 6 weeks :
- 1 session will take place in the Sports Medicine Department of the Croix Rousse Hospital
- 2 sessions will take place remotely. They will be led by an educator in Adapted Physical Activity in live video-conference.
Weekly phone call.Other
Patients included in the WL group will receive a weekly phone call for 6 weeks (waiting period), before starting the physical activity training program described above.
Personalized training plan.Other
After the training program, patients of both groups will be given a personalized training plan to be followed for 4 months with regular phone call from the Adapted Physical Activity educator.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment (IT) | Patients randomized to the IT group will begin the training sessions 14 days after the inclusion. Receives: Other: Physical activity training program; Other: Personalized training plan. | |
| Waiting list (WL) | Patients randomized to the WL group will receive a weekly phone call for 6 weeks.
Then, they will benefit the same training program as IT group (56 days after the inclusion). Receives: Other: Physical activity training program; Other: Weekly phone call.; Other: Personalized training plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.
The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
Measured: before and after 6 weeks of physical activity program (training period)
Secondary outcomes (12)
Narcolepsy Severity Scale (NSS) Score
The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
Measured: At 6 months
Compliance with the training program.
It will be expressed as the percentage of sessions completed
Measured: weekly during the training period (up to 6 weeks)
Hospital and Anxiety Depression Scale score
Measured: At inclusion, at the end of the training program (6 weeks) and at 6 months
Frequency of cataplexy
Items 8and 9 of the NSS are used to assess frequency of cataplexy
Measured: every week during de training period (6 weeks)
Bron/Lyon Attention Stability Test (BLAST) score
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
body mass index
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Maximal Oxygen consumption (VO2 max)
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
Fasting blood sugar
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Lipid profile
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
patient satisfaction score
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
sleep efficiency
Sleep efficiency is defined as the ratio between total sleeping time and time spent in bed
Measured: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Euroquol 5 dimensions questionnaire score
Measured: At inclusion, at the end of the training program (6 weeks) and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start26 Aug 2022
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure PETER-DEREX, MD, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460052
- Sponsor's protocol ID
- 69HCL21_1430
- Acronym
- NARCOSPORT
- Status last verified
- Jan 2024
- First submitted
- 23 May 2022
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ricordeau F, Stauffer E, Putois B, Jaffiol A, Cheylus A, Pouilloux G, Gabriel K, Hoarau E, Bastuji H, Franco P, Herbillon V, Capelle T, Joubert F, Pradat P, Spiegel K, Peter-Derex L. Feasibility and efficacy of exercise training on sleep symptoms and comorbidities in narcolepsy type 1: a prospective interventional study. Sleep. 2026 Jan 13;49(1):zsaf272. doi: 10.1093/sleep/zsaf272.
PubMed 40928141
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
- ClinicalTrials.gov ID
- NCT05460052
- Acronym / sponsor ID
- NARCOSPORT / 69HCL21_1430
- Conditions
- Narcolepsy Type 1
- Keywords
- Narcolepsy, Chronic neurological disorder, Regular physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 15 Jul 2022 (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 Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
Detailed description
Narcolepsy Type 1 (NT1) is a rare chronic neurological disorder resulting from the selective loss of hypocretin neurons. Patients with NT1 suffer from excessive daytime sleepiness, disrupted nighttime sleep, and cataplexy (emotionally triggered episodes of muscle atonia). The disease is associated with numerous comorbidities such as obesity, metabolic disorders, anxiety-depressive disorders, and attentional disorders, all of which have a strong impact on quality of life.
Current management is based on sleep hygiene as well as wake-promoting and anti-cataplectic medications. However, many patients complain of residual sleepiness or cataplexy. In addition, most of the proposed treatments are accompanied by side effects and have little effect on the comorbidities associated with the disease. Therapeutic alternatives are therefore needed in the management of narcolepsy.
Regular Physical Activity (RPA) is recommended by the World Health Organization (WHO) and has been shown to improve anxiety disorders, obesity, metabolic disorders, cognitive functions, sleep and quality of life.
In NT1, patients have fewer opportunities to practice RPA because of daytime sleepiness as well as increased sleep needs. Some studies suggest that cardiorespiratory performances may be lower in NT1 patients than in healthy controls, and that a higher level of physical activity may be associated with lower sleepiness and better metabolic profile in NT1 children. However, no prospective study has evaluated the feasibility of an exercise training program in NT1 or the effect of regular physical activity on disease severity.
The main objective of the study is to evaluate the effect of a physical activity training program of 3 sessions per week for 6 weeks on the severity of narcolepsy in sedentary adults with NT1.
The secondary objectives are to evaluate the feasibility of this program in an adult NT1 population, the effect of the program on comorbidities (obesity, metabolic disorders, anxiety-depressive symptoms, cognitive disorders), medication dosage and quality of life, its tolerance, and the satisfaction of the patients at short- (6 weeks) and long-term (6 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment (IT) | – | Other: Physical activity training program, Other: Personalized training plan.Patients randomized to the IT group will begin the training sessions 14 days after the inclusion. |
| Waiting list (WL) | – | Other: Physical activity training program, Other: Weekly phone call., Other: Personalized training plan.Patients randomized to the WL group will receive a weekly phone call for 6 weeks. Then, they will benefit the same training program as IT group (56 days after the inclusion). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with type 1 narcolepsy, sedentary, aged 18 to 65 years. The patients will be recruited from the active file of adult NT1 patients followed in the Sleep Center of the University Hospital of Lyon.
Key inclusion criteria (5 listed)
- Diagnosis of Narcolepsy type 1 according to International Classification of Sleep Disorders, 3rd edition (ICSD 3-2014) criteria
- Patients aged 18 to 65 years
- Patients beneficiaries of social security
- Signed consent to participate in the study
- Access to a video conferencing device (smartphone, tablet or computer)
Key exclusion criteria (11 listed)
- - Patients with a high level of physical activity on the Ricci and Gagnon Questionnaire (score >35) and/or regular physical activity in clubs
- Treatments not stabilized for less than 3 months
- Cognitive disorders incompatible with the understanding and implementation of the program
- Medical contraindication to exercise training
- Patient working night shifts
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 |
|---|---|---|
| Physical activity training programThe physical activity training program will consist of 3 sessions per week for 6 weeks : * 1 session will take place in the Sports Medicine Department of the Croix Rousse Hospital * 2 sessions will take place remotely. They will be led by an educator in Adapted Physical Activity in live video-conference. | Other | Immediate treatment (IT), Waiting list (WL) |
| Weekly phone call.Patients included in the WL group will receive a weekly phone call for 6 weeks (waiting period), before starting the physical activity training program described above. | Other | Waiting list (WL) |
| Personalized training plan.After the training program, patients of both groups will be given a personalized training plan to be followed for 4 months with regular phone call from the Adapted Physical Activity educator. | Other | Immediate treatment (IT), Waiting list (WL) |
Primary outcome
Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.
Time frame: before and after 6 weeks of physical activity program (training period)
The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
12 secondary outcomes
Narcolepsy Severity Scale (NSS) Score
Time frame: At 6 months
Compliance with the training program.
Time frame: weekly during the training period (up to 6 weeks)
Hospital and Anxiety Depression Scale score
Time frame: At inclusion, at the end of the training program (6 weeks) and at 6 months
Frequency of cataplexy
Time frame: every week during de training period (6 weeks)
Bron/Lyon Attention Stability Test (BLAST) score
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
body mass index
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Maximal Oxygen consumption (VO2 max)
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
Fasting blood sugar
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Lipid profile
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
patient satisfaction score
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
sleep efficiency
Time frame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Euroquol 5 dimensions questionnaire score
Time frame: At inclusion, at the end of the training program (6 weeks) and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Derived from this study: PubMed 40928141Ricordeau F, Stauffer E, Putois B, Jaffiol A, Cheylus A, Pouilloux G, Gabriel K, Hoarau E, Bastuji H, Franco P, Herbillon V, Capelle T, Joubert F, Pradat P, Spiegel K, Peter-Derex L. Feasibility and efficacy of exercise training on sleep symptoms and comorbidities in narcolepsy type 1: a prospective interventional study. Sleep. 2026 Jan 13;49(1):zsaf272. doi: 10.1093/sleep/zsaf272.
- Individual participant dataSharing planned: No
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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.
Laure PETER-DEREX, MD, PhD principal investigator
Hospices Civils de Lyon
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 Type 1, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 10 Jan 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Narcolepsy Severity Scale (NSS) Score after training period. (time frame: before and after 6 weeks of physical activity program (training period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05460052, which also lists 1 linked publication.
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 10 Jan 2024.