An observational study in Narcolepsy Type 1, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Hospices Civils de Lyon · Observational
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.
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).
149 studies on the registry are indexed under Narcolepsy; 33 are open to participants now.
This study's enrollment of 30 is below the median of 120 across 34 observational studies indexed under Narcolepsy.
Browse Narcolepsy studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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.
Exclusion Criteria:
Patients randomized to the IT group will begin the training sessions 14 days after the inclusion.
Other: Physical activity training program · 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).
Other: Physical activity training program · Other: Weekly phone call. · Other: Personalized training plan.
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.
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.
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.
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
Time frame: before and after 6 weeks of physical activity program (training period)
Narcolepsy Severity Scale (NSS) Score
The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
Time frame: At 6 months
Compliance with the training program.
It will be expressed as the percentage of sessions completed
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
Items 8and 9 of the NSS are used to assess 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
Sleep efficiency is defined as the ratio between total sleeping time and time spent in bed
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
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon