Investigating Circadian Rhythms in Youth With Persistent Tic Disorders
NCT ID: NCT03508245
Last Updated: 2023-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2018-01-18
2023-06-23
Brief Summary
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Detailed Description
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Study participation will take place over a three-week period. Clinician-rated tic interview and rating scales of morningness-eveningness preference, sleep, tic, and other symptoms will be completed during an initial screening assessment. Participants will then monitor sleep at home using an actigraph for one week and return for a baseline clinical assessment of tic severity and evening assessment of internal melatonin levels involving saliva sampling every 30 minutes for 6.5 hours in a dimly lit room. Next, participants will complete an abbreviated course (i.e., two weeks) of morning light therapy using wearable short wavelength (i.e., blue-green) light-emitting glasses while continuing to monitor sleep using the actigraph. Following this two-week period participants will return for a final assessment of tic severity and internal melatonin levels.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Wearable short wavelength light therapy
Wearable short wavelength light therapy
Wearable short wavelength light therapy
Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
Interventions
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Wearable short wavelength light therapy
Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Yale Global Tic Severity Scale Score ≥ 14 for Tourette's Disorder or ≥ 10 for Persistent Motor Tic Disorder or Persistent Vocal Tic Disorder
3. fluency in English
Exclusion Criteria
2. Suicidality, severe depression or anxiety (i.e., Depression or anxiety diagnosis is more severe than Tourette's Disorder; equivalence in severity is allowed), or substance dependence, present within the past 6 months
3. Current diagnosis of Obstructive Sleep Apnea, Restless leg syndrome, Periodic Limb Movement Disorder, or Narcolepsy
4. Intellectual functioning below the low average range (WASI-II IQ score \< 80)
5. Hypnotic medications, or melatonin within 8 weeks of study enrollment
6. Changes in dosage of any psychiatric medications within the past month
7. Behavior therapy for tics within the past 3 months
8. Prior use of light therapy
9. Current pregnancy or travel across \> 2 time zones in the past month
10. Medical or neurological condition (e.g., seizure disorder, migraines) that would interfere in the individual's ability to participate in the study
13 Years
17 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Emily J. Ricketts, PhD
Principal Investigator
Principal Investigators
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Emily J Ricketts, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
Los Angeles, California, United States
Countries
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References
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Carskadon MA, Vieira C, Acebo C. Association between puberty and delayed phase preference. Sleep. 1993 Apr;16(3):258-62. doi: 10.1093/sleep/16.3.258.
Chang S, Himle MB, Tucker BTP, Woods DW. Initial psychometric properties of a brief-parent-report instrument for assessing tic severity in children with chronic tic disorders. Child and Family Behavior Therapy 31(3): 181-191, 2009.
Coles ME, Strauss GP. Shedding light on tics. Psychiatry Res. 2015 Feb 28;225(3):743. doi: 10.1016/j.psychres.2014.12.024. Epub 2014 Dec 23. No abstract available.
Guy W. ECDEU assessment manual for psychopharmacology. Rev. Rockville, Md.: National Institute of Mental Health. (DHEW publication no. (ADM) 76-338), 1976.
Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. doi: 10.1097/00004583-198907000-00015.
Niederhofer H. Bright light therapy may be a therapeutic option for Tourette's syndrome. Acta Neuropsychologica 7(4): 283-285, 2009.
Other Identifiers
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17-000869
Identifier Type: -
Identifier Source: org_study_id