Clinical trial NCT05460052: Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
Official title: Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narcolepsy Type 1
Keywords: Narcolepsy
Chronic neurological disorder
Regular physical activity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* - 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
* 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

Primary outcomes:
measure: Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.
timeFrame: before and after 6 weeks of physical activity program (training period)
Secondary outcomes:
measure: Narcolepsy Severity Scale (NSS) Score
timeFrame: At 6 months
measure: Compliance with the training program.
timeFrame: weekly during the training period (up to 6 weeks)
measure: Hospital and Anxiety Depression Scale score
timeFrame: At inclusion, at the end of the training program (6 weeks) and at 6 months
measure: Frequency of cataplexy
timeFrame: every week during de training period (6 weeks)
measure: Bron/Lyon Attention Stability Test (BLAST) score
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
measure: body mass index
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
measure: Maximal Oxygen consumption (VO2 max)
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
measure: Fasting blood sugar
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
measure: Lipid profile
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
measure: patient satisfaction score
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks)
measure: sleep efficiency
timeFrame: Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
measure: Euroquol 5 dimensions questionnaire score
timeFrame: At inclusion, at the end of the training program (6 weeks) and at 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de médecine du sommeil et des maladies respiratoires
Study officials:
affiliation: Hospices Civils de Lyon
name: Laure PETER-DEREX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: