Clinical trial: Awareness and Self-Compassion Enhancing Narcolepsy Treatment (NCT04306952)

Eligibility criteria:
Inclusion Criteria:

          1. Males and females age 18 and older (except when the age of majority for a state
             differs from 18, including Delaware [19 years or older], Mississippi [21 years or
             older], and Nebraska [19 years or older])

          2. ICSD-3 criteria (8) for Narcolepsy (Type I or II)

          3. Endorse current psychological distress based on a t-score ≥ 60 on the PROMIS
             depression or anxiety scales

          4. Established standard care for narcolepsy. Patients who have not been previously
             diagnosed will be required to complete a clinical work-up through a sleep clinic
             (i.e., nocturnal PSG followed by a next-day MSLT) before participating. Standard care
             is managed outside of the study.

        Exclusion Criteria:

          1. Hypersomnia not of central origin (i.e., hypersomnia attributed to psychiatric
             disorder, medical disorder, other sleep disorder such as circadian rhythm sleep
             disorder, or insufficient sleep).

          2. Current suicidal ideation or intent.

          3. Uncontrolled medical conditions or physical limitations that require immediate medical
             treatment that would prevent ability to engage in the treatment protocol.

          4. Inability to engage in the treatment protocol due to a psychiatric (e.g., psychotic
             disorder) or cognitive issue.

          5. Untreated moderate-to-severe sleep-related breathing disorder, defined as an apnea
             hypopnea index (AHI) ≥ 15. Those receiving treatment for a sleep-related breathing
             disorder and can demonstrate adequate management (e.g., residual AHI < 5) will be
             allowed to participate.

          6. Previous participation in a formal MBI program, such as MBSR.

          7. Unstable dose of medications at the time of screening (e.g., stimulants).

          8. Unable to attend intervention sessions due to accessibility (i.e., reliable internet
             connection) or availability (i.e., not available due to scheduling conflicts).

          9. Currently living outside of the United States.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 100 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