Clinical trial: 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy' (NCT04419792)

Eligibility criteria:
Inclusion Criteria:

          1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International
             Classification of Sleep Disorders, third edition (ICSD-3) criteria for at least 6
             months - diagnosis for at least 6 months will ensure that initial fluctuations due to
             likely starting on new drug regimen are relatively stable.

          2. Eligibility screened and agreement of the participant's treating clinician in
             Narcolepsy out-patient clinic of St. James's Hospital that he/she can participate - to
             ensure that as per General Data Protection Regulation guidelines that the treating
             clinician eligibility screens rather than the physiotherapy study researcher.

          3. Patients aged ≥18 to <65 years at the time of obtaining informed consent - as patients
             >18 years will not been seen in this centre, and patients >65 years may have
             age-related changes in cardiovascular fitness and physical activity which may be
             difficult to separate from those pertaining to narcolepsy diagnosis.

          4. Able to understand English - as questionnaires will necessitate a sufficient level of
             English for completion.

        Exclusion Criteria:

          1. Patients with sleep disorders other than narcolepsy (e.g., moderate to severe sleep
             apnea syndrome, moderate to severe periodic limb movement disorder) - so results are
             not diluted by including conditions other than narcolepsy.

          2. Any medical contraindication to exercise of moderate intensity and short duration
             including but not limited to cardiovascular or respiratory conditions, morbid obesity,
             and severe osteoarthritis of the lower extremities - as these conditions would
             preclude ability to conduct physical test battery.

          3. Confirmed pregnancy - people with an advanced pregnancy may score differently on
             physical functioning/performance tests, people with a confirmed pregnancy will be
             excluded from study participation to limit bias.

          4. Dementia or significant cognitive impairment or psychiatric illness that would
             preclude ability to participate in study.
No condition on gender to be admitted to the trial.

Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 25-year-old woman comes to the clinic with her roommate.  The roommate says that the patient has twice fallen asleep while they were talking.  The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap.  She also reveals that she sometimes hears a voice prior to falling asleep.  She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately.

Patient description (patient's own words): I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep.

Does the patient match the trial criteria? Entailment