NarcolepsyTENARNCT04316286
TElemedicine for NARcolepsy
A study testing Tele-multidisciplinary care in people with Narcolepsy, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- Tele-multidisciplinary care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2020to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- inability to read, write, or using a tablet;
- major psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With 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.
- Conditions
- Narcolepsy
- Being tested
- Tele-multidisciplinary care, Standard care
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-multidisciplinary careProcedure or surgery
Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists
Standard careOther
Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists
| Study group | Role | What they receive |
|---|---|---|
| Tele-multidisciplinary participants | Experimental | Patients undergoing televisit Receives: Procedure: Tele-multidisciplinary care |
| In-office standard participants | Other | Patients undergoing in-office visits Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (10)
metabolic control - weight Changes
metabolic control - weight Changes of weight in kilograms. [Time frame: 12 months]
Measured: 12 months
metabolic control - lipid profile Changes
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]
Measured: 12 months
metabolic control - glycemic profile Changes
metabolic control - glycemic profile Changes of fasting glycemia measured in milligrams per deciliter (mg/dl). [Time frame: 12 months]
Measured: 12 months
metabolic control - caloric intake Changes
metabolic control - caloric intake Changes of caloric intake measured by a food diary. [Time frame: 12 months]
Measured: 12 months
metabolic control - physical activity Changes
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]
Measured: 12 months
quality of life - Short-Form 36-Item Questionnaire
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]
Measured: 12 months
quality of life - Pediatric Quality of Life Inventory
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]
Measured: 12 months
patient and family satisfaction with care
patient and family satisfaction with care, measured by an ad-hoc devised form (named Co-Tenar), assessing qualitatively the satisfaction level.
Measured: 12 months
safety
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).
Measured: 12 months
costs
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start1 Apr 2020
- Primary completion24 Nov 2022
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Collaborators
- University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna
- Responsible party
- Sponsor
- Investigators
- Giuseppe Plazzi, Principal investigator, IRCCS Istituto delle Scienze Neurologiche di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316286
- Sponsor's protocol ID
- RF-2016-02364742
- Acronym
- TENAR
- Status last verified
- Jun 2023
- First submitted
- 30 Jan 2020
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32393279
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine With Mobile Internet Devices for Innovative Multidisciplinary Patient-centred Care of Patients With Narcolepsy
- ClinicalTrials.gov ID
- NCT04316286
- Acronym / sponsor ID
- TENAR / RF-2016-02364742
- Conditions
- Narcolepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Collaborators
- University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS Istituto delle Scienze Neurologiche di Bologna
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-multidisciplinary participants | Experimental | Procedure: Tele-multidisciplinary carePatients undergoing televisit |
| In-office standard participants | Other | Other: Standard carePatients undergoing in-office visits |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- inability to read, write, or using a tablet;
- major psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-multidisciplinary careScheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists | Procedure or surgery | Tele-multidisciplinary participants |
| Standard careScheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists | Other | In-office standard participants |
Primary outcome
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
10 secondary outcomes
metabolic control - weight Changes
Time frame: 12 months
metabolic control - lipid profile Changes
Time frame: 12 months
metabolic control - glycemic profile Changes
Time frame: 12 months
metabolic control - caloric intake Changes
Time frame: 12 months
metabolic control - physical activity Changes
Time frame: 12 months
quality of life - Short-Form 36-Item Questionnaire
Time frame: 12 months
quality of life - Pediatric Quality of Life Inventory
Time frame: 12 months
patient and family satisfaction with care
Time frame: 12 months
safety
Time frame: 12 months
costs
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Derived from this study: PubMed 32393279Ingravallo 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.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Plazzi principal investigator
IRCCS Istituto delle Scienze Neurologiche di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-multidisciplinary care in people with Narcolepsy, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
excessive daytime sleepiness (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.