Clinical Trial Summary

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Phase

N/A

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Funding Agency/Sponsor

Other

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Disease

Movement Disorders

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Enrollment Eligibility

Inclusion Criteria:
1. Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical
Diagnostic Criteria for Parkinson's disease;
2. PD Hoehn and Yahr stage 2-4;
3. A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
4. Stable dose of all PD medications for at least 30 days prior to randomization;
5. Willingness to wear an Actiwatch and complete daily sleep logs;
6. Age 45 or above
Exclusion Criteria:
1. Atypical or secondary forms of parkinsonism;
2. Co-existent significant sleep apnea at screening, as determined by the PI's clinical
assessment; adequately treated sleep apnea, as assessed by sleep apnea machine
download (CPAP download) will be permitted;
3. Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International
Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
4. Cognitive impairment as determined by a Mini Mental State Examination score <25 at
screening;
5. Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II)
score ≥20 at screening;
6. Current untreated hallucinations or psychosis (drug-induced or spontaneous) with a
score of 2 or above on the Hallucinations and Psychosis question of the MDS-UPDRS Part
2;
7. Use of hypno-sedative drugs for sleep or stimulants, unless the participant has been
on a stable dose for at least 60 days prior to the screening;
8. Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for
Insomnia;
9. Use of antidepressants, unless the participant has been on a stable dose for at least
60 days prior to the screening;
10. Work hours between 10 PM and 6 AM, within 60 days prior to randomization or
anticipated during the 16 weeks after screening;
11. Travel between 3 or more time zones within 45 days prior to study screening or
anticipated such travel during the 16 weeks after screening;
12. Unstable or serious medical illness;
13. History of significant eye trauma or disease, retinopathy, or cataract Grade 4 that
would significantly affect transmission or processing of light through either eye;
14. Current use, use at any time during study participation, or use within the 30 days
prior to screening of photosensitizing or other medications that in the opinion of the
investigator would interfere with the safety of the participant during the trial,
including: amiodarone, porfimer, psoralens, chlorpromazine, quinidine, demeclocycline,
temoporfin, tetracycline, fleroxacin, oral isoretinoin, voriconazole, nalidixic acid,
thioridazine, St. John's wort, ofloxacin, and piroxicam;
15. Pregnant women will be excluded from participation; if a participant is
pre-menopausal, a urine pregnancy test will be conducted at randomization to determine
eligibility.

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