Status:
COMPLETED
Awareness and Self-Compassion Enhancing Narcolepsy Treatment
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Narcolepsy
Narcolepsy Without Cataplexy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 n...
Detailed Description
Narcolepsy is a serious and debilitating condition involving persistent and excessive sleepiness that affects 1 in 2000 Americans and 3 million people worldwide. Although wake-promoting pharmacotherap...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04306952
Start Date
June 15 2020
End Date
June 30 2022
Last Update
August 20 2024
Active Locations (1)
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1
Center for Circadian and Sleep Medicine, Northwestern University
Chicago, Illinois, United States, 60611