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TElemedicine for NARcolepsy

NCT04316286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2023-06-07

No results posted yet for this study

Summary

The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy.

Open RCT assessing the non-inferiority of the multidisciplinary management of narcolepsy via Video Consultation (VC) through Mobile Telemedicine devices compared to usual in-office care. 202 children and adults with narcolepsy will be randomly allocated in 1:1 ratio to VC or in-office usual care for a 12 months follow-up. At baseline, all patients will undergo a neurologic, metabolic, and psychosocial assessment. Primary (i.e., excessive daytime sleepiness according to the Epworth Sleepiness Scale) and secondary endpoints (i.e., other symptoms, metabolic control, quality of life, patient and family satisfaction with care, feasibility, safety, and costs) will be measured at 6 and 12 months. The investigators expect the Telemedicine approach not only to be non-inferior for sleepiness control but also to significantly improve other patient-centred outcomes compared to the usual in-office care.

Conditions

Interventions

PROCEDURE

Tele-multidisciplinary care

Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists

OTHER

Standard care

Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    collaborator OTHER

  • IRCCS Istituto delle Scienze Neurologiche di Bologna

    collaborator OTHER

  • Azienda Usl di Bologna

    lead OTHER_GOV

Principal Investigators

  • Giuseppe Plazzi · IRCCS Istituto delle Scienze Neurologiche di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-11-24
Completion
2023-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316286 on ClinicalTrials.gov