Awareness and Self-Compassion Enhancing Narcolepsy Treatment

Completed · Not applicable

Conditions studied: Narcolepsy, Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy

In brief

The overall goal of this research is to test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related quality of life as a complementary practice to standard care for narcolepsy. This study is a feasibility trial in which 60 adults with narcolepsy will be randomized to receive either a 4-week (brief), 8-week (standard), or 12-week (extended) MBI. Each MBI will be delivered in small groups using a live videoconferencing platform and teaches mindfulness practices to help cope with narcolepsy symptoms. By developing a scalable mind-body intervention, this project can addresses a major research gap on improving psychosocial functioning in people with narcolepsy.

Key facts

Study ID

NCT04306952

Run by

Northwestern University

People needed

60

Starts

2020-06-15

Expected to finish

2022-06-30

Last updated by the study team

2024-08-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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])
• ICSD-3 criteria (8) for Narcolepsy (Type I or II)
• Endorse current psychological distress based on a t-score ≥ 60 on the PROMIS depression or anxiety scales
• 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.

You may not qualify if…

• 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).
• Current suicidal ideation or intent.
• Uncontrolled medical conditions or physical limitations that require immediate medical treatment that would prevent ability to engage in the treatment protocol.
• Inability to engage in the treatment protocol due to a psychiatric (e.g., psychotic disorder) or cognitive issue.
• 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.
• Previous participation in a formal MBI program, such as MBSR.
• Unstable dose of medications at the time of screening (e.g., stimulants).
• Unable to attend intervention sessions due to accessibility (i.e., reliable internet connection) or availability (i.e., not available due to scheduling conflicts).
• Currently living outside of the United States.

Where it is running

• Center for Circadian and Sleep Medicine, Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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