NCT05460052

Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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). 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).

Conditions

• Narcolepsy Type 1

Interventions

Type	Name	Description
OTHER	Physical activity training program	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.
OTHER	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	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.

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-11-24
• Completion: 2023-11-24
• First posted: 2022-07-15
• Last updated: 2024-01-10

Locations

1 site across 1 country: France