NCT04316286

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

January 30, 2020

Last Update Submit

June 6, 2023

Conditions

Narcolepsy

Outcome Measures

Primary Outcomes (1)

  • excessive daytime sleepiness

    Measured by the Epworth Sleepiness Scale. The Epworth Sleepiness Scale is a self-administered form with eight items investigating sleep propensity in different real-life situations during the preceding months. Each item can received 0-3 points, thus the final score ranges from 0 (best score) to 24 (worse score). The proposed range for normal subjects is 0-10

    12 months

Secondary Outcomes (10)

  • metabolic control - weight Changes

    12 months

  • metabolic control - lipid profile Changes

    12 months

  • metabolic control - glycemic profile Changes

    12 months

  • metabolic control - caloric intake Changes

    12 months

  • metabolic control - physical activity Changes

    12 months

  • +5 more secondary outcomes

Study Arms (2)

Tele-multidisciplinary participants

EXPERIMENTAL

Patients undergoing televisit

Procedure: Tele-multidisciplinary care

In-office standard participants

OTHER

Patients undergoing in-office visits

Other: Standard care

Interventions

Tele-multidisciplinary carePROCEDURE

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

Tele-multidisciplinary participants
Standard careOTHER

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

In-office standard participants

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents (≥14 years old) and adults with a diagnosis of narcolepsy according to ICSD-3 criteria at their first ("incident") or with established diagnosis ("prevalent" subjects), able to provide consent

You may not qualify if:

  • inability to read, write, or using a tablet;
  • major psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs - Istituto Delle Scienze Neurologiche

Bologna, 40139, Italy

Location

Related Publications (1)

  • Ingravallo F, Vignatelli L, Pagotto U, Vandi S, Moresco M, Mangiaruga A, Oriolo C, Zenesini C, Pizza F, Plazzi G. Protocols of a diagnostic study and a randomized controlled non-inferiority trial comparing televisits vs standard in-person outpatient visits for narcolepsy diagnosis and care: TElemedicine for NARcolepsy (TENAR). BMC Neurol. 2020 May 11;20(1):176. doi: 10.1186/s12883-020-01762-9.

    PMID: 32393279DERIVED

MeSH Terms

Conditions

Narcolepsy

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disorders of Excessive SomnolenceSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Giuseppe Plazzi

    IRCCS Istituto delle Scienze Neurologiche di Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2020

First Posted

March 20, 2020

Study Start

April 1, 2020

Primary Completion

November 24, 2022

Study Completion

May 31, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)