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

Completed

• Conditions: Narcolepsy Type 1
• Interventions: Other: Physical activity training program; Other: Personalized training plan.; Other: Weekly phone call.

• Registration Number: NCT05460052
• Lead Sponsor: Hospices Civils de 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Study Start: 2022-08-26
• Primary Completion: 2023-11-24
• Study Completion: 2023-11-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immediate treatment (IT)	Physical activity training program	Patients randomized to the IT group will begin the training sessions 14 days after the inclusion.
Immediate treatment (IT)	Personalized training plan.	Patients randomized to the IT group will begin the training sessions 14 days after the inclusion.
Waiting list (WL)	Weekly phone call.	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).
Waiting list (WL)	Physical activity training program	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).
Waiting list (WL)	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).

Primary Outcome Measures

Name	Time	Method
Change from baseline Narcolepsy Severity Scale (NSS) Score after training period.	before and after 6 weeks of physical activity program (training period)	The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1

Secondary Outcome Measures

Name	Time	Method
Narcolepsy Severity Scale (NSS) Score	At 6 months	The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1
Hospital and Anxiety Depression Scale score	At inclusion, at the end of the training program (6 weeks) and at 6 months
Frequency of cataplexy	every week during de training period (6 weeks)	Items 8and 9 of the NSS are used to assess frequency of cataplexy
Lipid profile	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
sleep efficiency	Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*	Sleep efficiency is defined as the ratio between total sleeping time and time spent in bed
Compliance with the training program.	weekly during the training period (up to 6 weeks)	It will be expressed as the percentage of sessions completed
body mass index	Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Bron/Lyon Attention Stability Test (BLAST) score	Parameters will be measured at inclusion, at the end of the training program (6 weeks)
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*
patient satisfaction score	Parameters will be measured at inclusion, at the end of the training program (6 weeks)

Trial Locations

Locations (1)

Service de médecine du sommeil et des maladies respiratoires; 🇫🇷 Lyon, France