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

NCT05460052 | Completed

• 1 other identifier: 69HCL21_1430
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcolepsy Type 1

Keywords

Narcolepsy; Chronic neurological disorder; Regular physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Narcolepsy Severity Scale (NSS) Score

  At 6 months

• Compliance with the training program.

  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

  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)

Study Arms (2)

Immediate treatment (IT)

Patients randomized to the IT group will begin the training sessions 14 days after the inclusion.

Other: Physical activity training program; Other: Personalized training plan.

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; Other: Weekly phone call.; Other: Personalized training plan.

Interventions

Physical activity training program OTHER

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.

Immediate treatment (IT); Waiting list (WL)

Weekly phone call. OTHER

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.

Waiting list (WL)

Personalized training plan. OTHER

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.

Immediate treatment (IT); Waiting list (WL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de médecine du sommeil et des maladies respiratoires

Lyon, 69004, France

Location

Related Publications (1)

• Ricordeau F, Stauffer E, Putois B, Jaffiol A, Cheylus A, Pouilloux G, Gabriel K, Hoarau E, Bastuji H, Franco P, Herbillon V, Capelle T, Joubert F, Pradat P, Spiegel K, Peter-Derex L. Feasibility and efficacy of exercise training on sleep symptoms and comorbidities in narcolepsy type 1: a prospective interventional study. Sleep. 2026 Jan 13;49(1):zsaf272. doi: 10.1093/sleep/zsaf272.

  PMID: 40928141 DERIVED

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Laure PETER-DEREX, MD, PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: July 15, 2022
• Study Start: August 26, 2022
• Primary Completion: November 24, 2023
• Study Completion: November 24, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)