Here is the design of a clinical trial:

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

Included conditions:
- Narcolepsy

Study Armgroups:
- {'label': 'Tele-multidisciplinary participants', 'type': 'EXPERIMENTAL', 'description': 'Patients undergoing televisit', 'interventionNames': ['Procedure: Tele-multidisciplinary care']}
- {'label': 'In-office standard participants', 'type': 'OTHER', 'description': 'Patients undergoing in-office visits', 'interventionNames': ['Other: Standard care']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Tele-multidisciplinary care', 'description': 'Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists', 'armGroupLabels': ['Tele-multidisciplinary participants']}
- {'type': 'OTHER', 'name': 'Standard care', 'description': 'Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists', 'armGroupLabels': ['In-office standard participants']}

Primary Outcomes:
- {'measure': 'excessive daytime sleepiness', 'description': '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', 'timeFrame': '12 months'}

Please estimate the sample size based on the assumption: 
The significance level is set to ensure the 95% lower limit of one-sided CI is above the non-inferiority limit, with 80% power. A 15% dropout rate is considered. Repeated measures ANOVA will be used for comparison.
Sample size and statistical considerations
          A total of 176 patients (88 per arm) are required to prove that the 95% lower limit of one-sided CI will be above the non-inferiority limit of ââ1.5 ESS points difference (standard deviation of 4), with 80% of power. A previous RCT used a non-inferiority margin of 2 ESS points and 80% as minimal power to compare pitolisant versus modafinil in patients with narcolepsy [30]. As the TMC study will not test drugs, we decided to adopt a stricter margin (1.5 ESS points). The standard deviation value (Â±4) was based on the Italian validation study of ESS [28]. Considering 15% of dropouts, the sample was enlarged to 202 (101 per arm). Repeated measures ANOVA will be used to compare EDS between groups at baseline and after 1-yr of follow-up.