An interventional study of Brief MBI and Standard MBI in Narcolepsy, Narcolepsy Without Cataplexy and Narcolepsy With Cataplexy, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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Among 85 studies in Narcolepsy with a site in United States — 19 open to participants now, 20 under way, 8 of them phase 3. Narcolepsy · United States.
Among the 85 studies in Narcolepsy with a site in United States, this one is the 49th largest by enrollment of the 69 interventional ones that give a count, is one of 7 that started in 2020, is one of 8 with no phase, and was the 37th registered.
158 studies on the registry are indexed under Narcolepsy; 38 are open to participants now.
Browse Narcolepsy studies →19 of the 85 studies in Narcolepsy with a site in United States are open now. Recruiting first, the newest first:
Suven Life Sciences Limited · Sites in United States
Ages 18+
Jazz Pharmaceuticals · Sites in United States
Ages 18–75
University of Utah · Sites in United States
Ages 18+
Takeda · Sites in United States, Australia, China and 4 more countries
Ages 18–70
Harmony Biosciences Management, Inc. · Sites in United States, Belgium, Canada and 4 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 30 Narcolepsy studies recruiting now, 12 (40%) set no upper age limit and 16 (53%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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85 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 24 · Phase 3 24 · Phase 4 3
First in 1996; this study’s year is marked. 7 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.
Median enrollment 93 across the 69 interventional studies, 191 across the 15 observational. Of the 62 that completed or were terminated, 30 (48%) have results posted.
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66 of 85 have an industry lead sponsor. The 10 most frequent:
Northwestern University is the lead sponsor of 1,424 studies on the registry; 199 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Northwestern University has 3 studies filed under Narcolepsy — fewer than ten, so there is no comparison to draw.
11 of the studies in Narcolepsy with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07363720Phase 3TakedaA Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy | 2026-12-17 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT07598708Phase 3Centessa Pharmaceuticals (UK) LimitedA Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence | 2027-09-30 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
| NCT07540364Phase 3Suven Life Sciences LimitedA Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy (AWAKE) | 2027-11-19 |
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Among the 85 studies in Narcolepsy with a site in United States, from their registry updates:
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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.
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 pharmacotherapy can reduce sleepiness there is no cure and people with narcolepsy experience significantly poor health-related quality of life, particularly in the domains of mental and social health. Therefore, the overarching 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. The purpose of this study is to conduct a feasibility trial to determine the optimal parameters for adapting and delivering MBI to people with narcolepsy. The specific aims are to: 1) Determine the feasibility and acceptability of MBI delivered using videoconferencing for the purpose of improving psychosocial functioning in people with narcolepsy and 2) Determine the feasibility of recruitment and assessment methods for delivering MBI using videoconferencing. The feasibility trial includes 60 adults with narcolepsy who will be randomized to receive either a 4-week (brief), 8-week (standard), or 12-week (extended) MBI. Each MBI will be similar in content, which includes mindfulness practices and group discussions with adaptations for working with narcolepsy symptoms. All MBIs will be delivered in small groups using a live videoconferencing platform to enhance accessibility. If the findings of this project support the feasibility of further testing, the next project would be aimed at enhancing rigor and reproducibility (e.g., designing appropriate control, refining outcome measures and eligibility criteria) in preparation for a large-scale pragmatic trial. The overall significance of this research is to develop a scalable mind-body intervention that addresses a major research gap on improving psychosocial functioning in people with narcolepsy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat.
Behavioral: Brief MBI
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat.
Behavioral: Standard MBI
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks, with optional "office hours"in between the bi-weekly group sessions and one all day meditation retreat.
Behavioral: Extended MBI
The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer "office hours" in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours).
Number of Participants Who Attended ≥ 80% of Sessions
Number of participants who attended greater than or equal to 80% of sessions
Time frame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Number of Participants Who Practiced Meditation ≥ 4 Days Per Week
Number of participants who practiced meditation greater than or equal to 4 days per week
Time frame: 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Number of Participants Who Completed Assessments
Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)
Time frame: Baseline and 4 weeks (Brief MBI), 8 weeks (Standard MBI), or 12 weeks (Extended MBI)
Self-Compassion Scale (SCS)
The SCS assesses the acquisition of self-compassion. It is a 26-item self report measure with three main components of self-compassion: self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification. The total score ranges from 1-5, with higher scores reflecting more self-compassion.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Five Facet Mindfulness Questionnaire (FFMQ)
The FFMQ assesses the acquisition of mindfulness skills. It is a 39-item self-report measure that consists of five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-195, with higher scores reflecting more mindfulness.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Positive
Measures the direct positive psychosocial effect related to illness with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Psychosocial Illness Impact Negative Scale
Measures the direct negative psychosocial effect related to illness with higher scores reflecting worse outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale
Measures overall physical and mental health with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale
Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
Time frame: Baseline to post-treatment (Brief MBI 4 weeks, Standard MBI 8 weeks, Extended MBI 12 weeks)
| Milestone | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 20 | 16 | 19 |
| Not completed | 0 | 4 | 1 |
Number of participants who attended greater than or equal to 80% of sessions
| Participants | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Number of Participants Who Attended ≥ 80% of Sessions | 15 | 13 | 15 |
Number of participants who practiced meditation greater than or equal to 4 days per week
| Participants | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Number of Participants Who Practiced Meditation ≥ 4 Days Per Week | 16 | 8 | 13 |
Number of participants who completed entire baseline and post-treatment assessment (questionnaires, actigraphy, and neurocognitive testing)
| Participants | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Number of Participants Who Completed Assessments | 18 | 13 | 16 |
The SCS assesses the acquisition of self-compassion. It is a 26-item self report measure with three main components of self-compassion: self-kindness vs. self-judgement, common humanity vs. isolation, and mindfulness vs. over-identification. The total score ranges from 1-5, with higher scores reflecting more self-compassion.
| score on a scale | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 2.66 ± .80 | 2.91 ± .82 | 2.52 ± .50 |
| Post-treatment | 3.12 ± .86 | 3.58 ± .58 | 3.61 ± .61 |
The FFMQ assesses the acquisition of mindfulness skills. It is a 39-item self-report measure that consists of five factors representing elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-195, with higher scores reflecting more mindfulness.
| score on a scale | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 115.90 ± 24.80 | 122.50 ± 22.13 | 107.00 ± 13.43 |
| Post-treatment | 132.42 ± 21.91 | 144.00 ± 16.11 | 136.53 ± 19.42 |
Measures the direct positive psychosocial effect related to illness with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
| T-score | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 39.35 ± 8.00 | 42.07 ± 6.84 | 38.74 ± 7.23 |
| Post-treatment | 42.83 ± 8.92 | 46.94 ± 8.26 | 43.85 ± 9.02 |
Measures the direct negative psychosocial effect related to illness with higher scores reflecting worse outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
| T-score | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 60.94 ± 6.53 | 59.35 ± 5.28 | 62.59 ± 8.26 |
| Post-treatment | 58.70 ± 10.09 | 56.52 ± 6.24 | 57.28 ± 6.75 |
Measures overall physical and mental health with higher scores reflecting better outcomes. Population mean (T-score) of 50 with a standard deviation of 10.
| T-score | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Global Mental Health (Baseline) | 38.01 ± 7.89 | 40.43 ± 6.07 | 36.03 ± 7.82 |
| Global Mental Health (Post-treatment) | 41.17 ± 10.09 | 44.77 ± 7.35 | 42.73 ± 8.09 |
| Global Physical Health (Baseline) | 46.32 ± 7.46 | 43.85 ± 6.15 | 43.71 ± 6.44 |
| Global Physical Health (Post-treatment) | 47.41 ± 8.16 | 46.32 ± 6.82 | 45.12 ± 8.32 |
Measures anxiety symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
| T-score | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 62.54 ± 7.04 | 61.24 ± 4.85 | 61.69 ± 6.67 |
| Post-treatment | 62.46 ± 9.79 | 56.62 ± 6.25 | 58.04 ± 7.48 |
Measures depressive symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.
| T-score | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Baseline | 59.53 ± 4.76 | 56.11 ± 4.81 | 60.06 ± 6.25 |
| Post-treatment | 57.70 ± 9.08 | 53.89 ± 6.30 | 52.73 ± 6.08 |
Collected over 12 weeks (all groups). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief MBI | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Standard MBI | 0/20 (0%) | 1/20 (5%) | 5/20 (25%) |
| Extended MBI | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Event | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Stent placementCardiac disorders | 0/20 | 1/20 | 0/20 |
| Event | Brief MBI | Standard MBI | Extended MBI |
|---|---|---|---|
| Actigraphy-related skin irritationSkin and subcutaneous tissue disorders | 1/20 | 2/20 | 0/20 |
| Exacerbation of pre-existing depressionPsychiatric disorders | 2/20 | 0/20 | 0/20 |
| CystNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/20 | 0/20 | 0/20 |
| Car accidentInjury, poisoning and procedural complications | 0/20 | 1/20 | 0/20 |
| InfectionInfections and infestations | 0/20 | 1/20 | 1/20 |
| MigraineNervous system disorders | 0/20 | 1/20 | 0/20 |
| Increased sleepinessNervous system disorders | 1/20 | 0/20 | 0/20 |
| MelanomaSkin and subcutaneous tissue disorders | 1/20 | 0/20 | 0/20 |
| Age, Categorical(Participants) | Brief MBI | Standard MBI | Extended MBI | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 19 | 18 | 57 |
| >=65 years | 0 | 1 | 2 | 3 |
| Sex/Gender, Customized(Participants) | Brief MBI | Standard MBI | Extended MBI | Total |
|---|---|---|---|---|
| Female | 16 | 17 | 20 | 53 |
| Male | 3 | 2 | 0 | 5 |
| Non-binary | 1 | 1 | 0 | 2 |
| Ethnicity (NIH/OMB)(Participants) | Brief MBI | Standard MBI | Extended MBI | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 2 | 6 |
| Not Hispanic or Latino | 18 | 18 | 18 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Brief MBI | Standard MBI | Extended MBI | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 0 | 1 |
| White | 18 | 20 | 17 | 55 |
| More than one race | 0 | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Patient-Reported Outcomes Measurement Information System Depression(T-Score) | Brief MBI | Standard MBI | Extended MBI | Total |
|---|---|---|---|---|
| Mean | 59.53 ± 4.76 | 56.11 ± 4.81 | 60.06 ± 6.25 | 58.57 ± 5.52 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2020 to primary completion in May 2022, 23 months.
Results were first posted in Nov 2023, 1 year 5 months after primary completion.
Of 21 interventional studies with no phase under Narcolepsy, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's 23 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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