Evaluation of the Effectiveness of a Physical Activity Program on the Severity of Narcolepsy (NARCOSPORT)

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.

Study Overview

• Status: Completed
• Conditions: Narcolepsy Type 1
• Intervention / Treatment: Other: Physical activity training program; Other: Personalized training plan.; Other: Weekly phone call.

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Service de médecine du sommeil et des maladies respiratoires

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Immediate treatment (IT); Patients randomized to the IT group will begin the training sessions 14 days after the inclusion.	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: 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.
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).	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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Laure PETER-DEREX, MD, PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): November 24, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Narcolepsy; Chronic neurological disorder; Regular physical activity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: 69HCL21_1430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No