Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

TElemedicine for NARcolepsy (TENAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316286
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Collaborators:
University of Bologna
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IRCCS-Istituto delle scienze neurologiche di Bologna
Information provided by (Responsible Party):
Azienda Usl di Bologna

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.


Condition or disease Intervention/treatment Phase
Narcolepsy Procedure: Tele-multidisciplinary care Other: Standard care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tele-multidisciplinary participants
Patients undergoing televisit
Procedure: Tele-multidisciplinary care
Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists

In-office standard participants
Patients undergoing in-office visits
Other: Standard care
Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316286


Contacts
Layout table for location contacts
Contact: Luca Vignatelli +39 0514966197 l.vignatelli@ausl.bologna.it
Contact: Fabio Pizza +39 0514966924 fpizza@gmail.com

Locations
Layout table for location information
Italy
Azienda Unità Sanitaria Locale
Bologna, Italy, 40100
Sponsors and Collaborators
Azienda Usl di Bologna
University of Bologna
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
IRCCS-Istituto delle scienze neurologiche di Bologna
Investigators
Layout table for investigator information
Principal Investigator: Giuseppe Plazzi IRCCS-Istituto delle scienze neurologiche di Bologna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Azienda Usl di Bologna
ClinicalTrials.gov Identifier: NCT04316286    
Other Study ID Numbers: RF-2016-02364742
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders