Fatigue, Parkinson Disease, Sleep Disorder
Conditions
Keywords
Parkinson Disease, Light therapy
Brief summary
This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.
Detailed description
This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Interventions
DEVICESunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's Disease Sleep Scale 2 | 8 weeks | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's Fatigue Scale 16 | 8 weeks | The Parkinson's Fatigue Scale (PFS-16) is a 16-item patient-rated scale that measures the presence of fatigue and its impact on daily function in patients with Parkinson's Disease. The scale includes seven items assessing the presence of fatigue and nine items measuring its impact on daily activities. The scoring range for the PFS-16 is from 1 to 5 (range 16-80), with higher scores indicating more severe fatigue. The scale is designed to exclude cognitive and emotional features of fatigue and is used to assess levels of fatigue and measure changes in response to treatment or lifestyle changes. |
| Parkinson's Disease Sleep Scale 2 | 8 weeks | The PDSS-2 (Parkinson's Disease Sleep Scale 2) has a total score range from 0 to 60 points. Each item on the scale is scored on a scale of 0 to 4, with higher scores indicating more severe sleep problems. The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality. |
| Adherence | 8 weeks | The secondary objective of adherence centered on frequency of use. Participants recorded light exposure duration and timing daily using a LT log. For each prescribed active treatment dose frequency (once-daily BWLT, twice-daily BWLT), a binary measure of adherence was recorded for each expected day based on whether or not they completed LT at the correct frequency. The overall percentage of those days where participants completed LT at the correct frequency were compared between the two daily BWLT treatments using a generalized linear mixed model. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 133 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 39 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 5 / 37 | 7 / 39 | 4 / 37 | 5 / 37 |
| serious Total, serious adverse events | 1 / 37 | 0 / 39 | 1 / 37 | 3 / 37 |
Outcome results
None listed