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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment (IT) | Patients randomized to the IT group will begin the training sessions 14 days after the inclusion. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical activity training program | Other | The physical activity training program will consist of 3 sessions per week for 6 weeks :
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | before and after 6 weeks of physical activity program (training period) |
| Measure | Description | Time Frame |
|---|---|---|
| Narcolepsy Severity Scale (NSS) Score | The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1 | At 6 months |
| Compliance with the training program. | It will be expressed as the percentage of sessions completed |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Laure PETER-DEREX, MD, PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de médecine du sommeil et des maladies respiratoires | Lyon | 69004 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40928141 | Derived | 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. |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| 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. |
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| 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. |
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| weekly during the training period (up to 6 weeks) |
| Hospital and Anxiety Depression Scale score | 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 | every week during de training period (6 weeks) |
| Bron/Lyon Attention Stability Test (BLAST) score | Parameters will be measured at inclusion, at the end of the training program (6 weeks) |
| body mass index | Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months* |
| Maximal Oxygen consumption (VO2 max) | Parameters will be measured at inclusion, at the end of the training program (6 weeks) |
| Fasting blood sugar | Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months* |
| Lipid profile | Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months* |
| patient satisfaction score | 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 | Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months* |
| Euroquol 5 dimensions questionnaire score | At inclusion, at the end of the training program (6 weeks) and at 6 months |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |