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Completed

NCT Number: NCT04316286

TElemedicine for NARcolepsy

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.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Irccs - Istituto Delle Scienze Neurologiche

Bologna, 40139, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Tele-multidisciplinary care

Procedure

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

Standard care

Other

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

Primary outcomes

  1. excessive daytime sleepiness

    Time frame: 12 months

    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

Secondary outcomes

  1. metabolic control - weight Changes

    Time frame: 12 months

    metabolic control - weight Changes of weight in kilograms. [Time frame: 12 months]

  2. metabolic control - lipid profile Changes

    Time frame: 12 months

    metabolic control - lipid profile Changes of: total cholesterol; high-density lipoprotein cholesterol; low-density lipoprotein cholesterol; total triglycerides. All are measured in milligrams per deciliter (mg/dl).

    [Time frame: 12 months]

  3. metabolic control - glycemic profile Changes

    Time frame: 12 months

    metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). [Time frame: 12 months]

  4. metabolic control - caloric intake Changes

    Time frame: 12 months

    metabolic control - caloric intake Changes of caloric intake measured by a food diary. [Time frame: 12 months]

  5. metabolic control - physical activity Changes

    Time frame: 12 months

    metabolic control - physical activity Changes of physical activity measured by the International Physical Activity Questionnaire (IPAQ). Total physical activity is measured in MET-min/week and time spent sitting, and it is ranked in three levels: low; moderate; high.

    [Time frame: 12 months]

  6. quality of life - Short-Form 36-Item Questionnaire

    Time frame: 12 months

    Quality of life - Short-Form 36-Item Questionnaire (SF-36) Changes of SF-36 health related quality of life (HRQOL) scales. This tool presents 36 questions. Eight health domains are assessed (physical activities; social activities; limitations in role activities because of physical health problems; bodily pain; mental health; limitations in role activities because of emotional problems; vitality; general health perceptions). Each domain measures a level of HRQOL with a scale between 0-100, with 0 being bad quality of life and 100 being good.

    [Time frame: 12 months]

  7. quality of life - Pediatric Quality of Life Inventory

    Time frame: 12 months

    Quality of life - Pediatric Quality of Life Inventory (PedsQL) Changes of PedsQL health related quality of life (HRQOL) scales. This is a tool of 23 questions comprising four generic domains: physical functioning; emotional functioning; social functioning; school functioning. These domains are measured by a 0-100 scale. Higher scores indicate better HRQOL.

    [Time frame: 12 months]

  8. patient and family satisfaction with care

    Time frame: 12 months

    patient and family satisfaction with care, measured by an ad-hoc devised form (named Co-Tenar), assessing qualitatively the satisfaction level.

  9. safety

    Time frame: 12 months

    safety, in terms of number (percent) of full drop-outs, partial drop-outs (patients changing procedure), adverse reactions to drugs in both group of intervention (standard in-office visit arm, video-consultation arm).

  10. costs

    Time frame: 12 months

    costs related to the disease management (drugs, tests, hospitalization, journeys) will be assessed, by means of a standardized interview, in both group of intervention (standard in-office visit arm, video-consultation arm).

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna
  • IRCCS Istituto delle Scienze Neurologiche di Bologna
  • University of Bologna

Registry information

Official study title

Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy

Acronym: TENAR

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 20, 2020
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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