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

Narcolepsy Type 1 Clinical Trial

— NARCOSPORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05460052
• Other study ID #: 69HCL21_1430
• Status: Completed
• Start date: August 26, 2022
• Est. completion date: November 24, 2023

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 24, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcolepsy
• Narcolepsy Type 1

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Service de médecine du sommeil et des maladies respiratoires	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Narcolepsy Severity Scale (NSS) Score	The Narcolepsy Severity Scale is a validated scale exploring the different symptoms of NT1	At 6 months
Secondary	Compliance with the training program.	It will be expressed as the percentage of sessions completed	weekly during the training period (up to 6 weeks)
Secondary	Hospital and Anxiety Depression Scale score		At inclusion, at the end of the training program (6 weeks) and at 6 months
Secondary	Frequency of cataplexy	Items 8and 9 of the NSS are used to assess frequency of cataplexy	every week during de training period (6 weeks)
Secondary	Bron/Lyon Attention Stability Test (BLAST) score		Parameters will be measured at inclusion, at the end of the training program (6 weeks)
Secondary	body mass index		Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Secondary	Maximal Oxygen consumption (VO2 max)		Parameters will be measured at inclusion, at the end of the training program (6 weeks)
Secondary	Fasting blood sugar		Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Secondary	Lipid profile		Parameters will be measured at inclusion, at the end of the training program (6 weeks) and at 6 months*
Secondary	patient satisfaction score		Parameters will be measured at inclusion, at the end of the training program (6 weeks)
Secondary	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*
Secondary	Euroquol 5 dimensions questionnaire score		At inclusion, at the end of the training program (6 weeks) and at 6 months