Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01338649
• Collaborator: National Parkinson Foundation (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 59
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability.

Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Sleep Disorder; Excessive Somnolence	Device: Bright Light Treatment (Sun Ray Sunbox SB-558); Device: Dim red light (Sun Ray Sunbox SB-558)	N/A

Detailed Description

See above.

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bright White Exposure to bright white light treatment.	Device: Bright Light Treatment (Sun Ray Sunbox SB-558); Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.; Other Names: Sun Ray Sunbox SB-558
Placebo Comparator: Dim red light Exposure to dim red light treatment.	Device: Dim red light (Sun Ray Sunbox SB-558); Dim red light box administered during two 1 hour periods during the day using; Other Names: Sun Ray Sunbox SB-558

Outcome Measures

Primary Outcome Measures

1. Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. [baseline and 4 weeks]

   ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.

Secondary Outcome Measures

1. The Global PSQI Score and PDSS Score Will be Compared. [6 weeks]

   The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.

2. Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected. [6 weeks]

   Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.

3. MSLT and Polysomnograph (PSG) Testing Will be Compared. [4 weeks]

   MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria

2. Hoehn and Yahr stage of 2 to 4 in the "on" state

3. Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points

4. Stable PD medication regimen for at least 4 weeks prior to study screening

5. Willing and able to give written informed consent

Exclusion Criteria:

1. Atypical parkinsonian syndromes

2. Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)

3. Significant periodic limb movement disorder (defined as a PLM arousal index>10 events/hr of sleep on screening PSG) and REM sleep behavior disorder (based on the presence of both clinical symptomatology as well as intermittent loss of REM atonia on screening PSG)

4. Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24

5. Presence of depression defined as the Beck Depression Inventory (BDI) score >14

6. Untreated hallucinations or psychosis (drug-induced or spontaneous)

7. Use of hypno-sedative drugs for sleep or stimulants during the daytime

8. Use of antidepressants unless the patient has been on a stable dose for at least three months

9. Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness

10. Travel through 2 time zones within 90 days prior to study screening

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Parkinson Foundation

Investigators

• Principal Investigator: Aleksandar Videnovic, MD, MS, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Ancoli-Israel S, Gehrman P, Martin JL, Shochat T, Marler M, Corey-Bloom J, Levi L. Increased light exposure consolidates sleep and strengthens circadian rhythms in severe Alzheimer's disease patients. Behav Sleep Med. 2003;1(1):22-36.
• Ancoli-Israel S, Martin JL, Gehrman P, Shochat T, Corey-Bloom J, Marler M, Nolan S, Levi L. Effect of light on agitation in institutionalized patients with severe Alzheimer disease. Am J Geriatr Psychiatry. 2003 Mar-Apr;11(2):194-203.
• Artemenko AR, Levin IaI. [The phototherapy of parkinsonism patients]. Zh Nevrol Psikhiatr Im S S Korsakova. 1996;96(3):63-6. Russian.
• Czeisler CA, Allan JS, Strogatz SH, Ronda JM, Sánchez R, Ríos CD, Freitag WO, Richardson GS, Kronauer RE. Bright light resets the human circadian pacemaker independent of the timing of the sleep-wake cycle. Science. 1986 Aug 8;233(4764):667-71.
• Dhawan V, Healy DG, Pal S, Chaudhuri KR. Sleep-related problems of Parkinson's disease. Age Ageing. 2006 May;35(3):220-8. Review.
• Dijk DJ, Lockley SW. Integration of human sleep-wake regulation and circadian rhythmicity. J Appl Physiol (1985). 2002 Feb;92(2):852-62. Review.
• Dowling GA, Hubbard EM, Mastick J, Luxenberg JS, Burr RL, Van Someren EJ. Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. Int Psychogeriatr. 2005 Jun;17(2):221-36.
• Dowling GA, Mastick J, Hubbard EM, Luxenberg JS, Burr RL. Effect of timed bright light treatment for rest-activity disruption in institutionalized patients with Alzheimer's disease. Int J Geriatr Psychiatry. 2005 Aug;20(8):738-43.
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• Fetveit A, Bjorvatn B. Bright-light treatment reduces actigraphic-measured daytime sleep in nursing home patients with dementia: a pilot study. Am J Geriatr Psychiatry. 2005 May;13(5):420-3.
• Kaida K, Takahashi M, Haratani T, Otsuka Y, Fukasawa K, Nakata A. Indoor exposure to natural bright light prevents afternoon sleepiness. Sleep. 2006 Apr;29(4):462-9.
• Karlsen KH, Tandberg E, Arsland D, Larsen JP. Health related quality of life in Parkinson's disease: a prospective longitudinal study. J Neurol Neurosurg Psychiatry. 2000 Nov;69(5):584-9.
• Klerman EB, Duffy JF, Dijk DJ, Czeisler CA. Circadian phase resetting in older people by ocular bright light exposure. J Investig Med. 2001 Jan;49(1):30-40. doi: 10.2310/6650.2001.34088.
• Kobayashi R, Kohsaka M, Fukuda N, Sakakibara S, Honma H, Koyama T. Effects of morning bright light on sleep in healthy elderly women. Psychiatry Clin Neurosci. 1999 Apr;53(2):237-8.
• Kogan AO, Guilford PM. Side effects of short-term 10,000-lux light therapy. Am J Psychiatry. 1998 Feb;155(2):293-4.
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• Lockley SW, Skene DJ, Arendt J, Tabandeh H, Bird AC, Defrance R. Relationship between melatonin rhythms and visual loss in the blind. J Clin Endocrinol Metab. 1997 Nov;82(11):3763-70.
• Meindorfner C, Körner Y, Möller JC, Stiasny-Kolster K, Oertel WH, Krüger HP. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005 Jul;20(7):832-42.
• Mishima K, Okawa M, Shimizu T, Hishikawa Y. Diminished melatonin secretion in the elderly caused by insufficient environmental illumination. J Clin Endocrinol Metab. 2001 Jan;86(1):129-34.
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• Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. Review. Erratum in: Neurosci Biobehav Rev 1996 Summer;20(2):I-IV.
• Paus S, Brecht HM, Köster J, Seeger G, Klockgether T, Wüllner U. Sleep attacks, daytime sleepiness, and dopamine agonists in Parkinson's disease. Mov Disord. 2003 Jun;18(6):659-67.
• Phipps-Nelson J, Redman JR, Dijk DJ, Rajaratnam SM. Daytime exposure to bright light, as compared to dim light, decreases sleepiness and improves psychomotor vigilance performance. Sleep. 2003 Sep;26(6):695-700.
• Reid KJ, Burgess HJ. Circadian rhythm sleep disorders. Prim Care. 2005 Jun;32(2):449-73. Review.
• Rye DB, Bliwise DL, Dihenia B, Gurecki P. FAST TRACK: daytime sleepiness in Parkinson's disease. J Sleep Res. 2000 Mar;9(1):63-9.
• Scaravilli T, Gasparoli E, Rinaldi F, Polesello G, Bracco F. Health-related quality of life and sleep disorders in Parkinson's disease. Neurol Sci. 2003 Oct;24(3):209-10.
• Schindler SD, Graf A, Fischer P, Tölk A, Kasper S. Paranoid delusions and hallucinations and bright light therapy in Alzheimer's disease. Int J Geriatr Psychiatry. 2002 Nov;17(11):1071-2.
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• Responsible Party: Aleksandar Videnovic, Assistant Professor of Neurology, Northwestern University
• ClinicalTrials.gov Identifier: NCT01338649
• Other Study ID Numbers: Light Therapy in PD
• First Posted: Apr 19, 2011
• Last Update Posted: Sep 5, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Aleksandar Videnovic, Assistant Professor of Neurology, Northwestern University: Parkinson's disease; Daytime somnolence; Sleepiness; Light therapy
• Additional relevant MeSH terms: Parkinson Disease; Sleep Wake Disorders; Sleepiness

Study Results

Participant Flow

Arm/Group Title	Bright White	Dim Red Light
Arm/Group Description	Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day.	Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using
Period Title: Overall Study
STARTED	13	14
COMPLETED	13	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Bright White	Dim Red Light	Total
Arm/Group Description	Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day.	Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using	Total of all reporting groups
Overall Participants	13	14	27
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (6.9)	59.3 (11.3)	63.6 (9.9)
Sex: Female, Male (Count of Participants)
Female	9 69.2%	8 57.1%	17 63%
Male	4 30.8%	6 42.9%	10 37%
Region of Enrollment (participants) [Number]
United States	13 100%	14 100%	27 100%

Outcome Measures

1. Primary Outcome

Title	Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.
Description	ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness ESS will be taken and compared at screening and week 4 visits between the bright light exposure and dim-red light exposure groups.
Time Frame	baseline and 4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright White	Dim Red Light
Arm/Group Description	Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day.	Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using
Measure Participants	13	14
Mean (Standard Deviation) [score]	4.46 (2.54)	1.77 (3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bright White, Dim Red Light
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0211
	Comments
	Method	t-test, 2 sided
	Comments	t-test on two groups of differences

2. Secondary Outcome

Title	The Global PSQI Score and PDSS Score Will be Compared.
Description	The global PSQI and PDSS scores will be taken and compared at screening, week 4 and week 6 visits.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Actigraphy Measures Including Total Sleep Time, Sleep Efficiency, Sleep Fragmentation Index, Frequency of Naps, and Mean Activity Level (a Measurement of Daytime Function) Will be Collected.
Description	Actigraphy measures including total sleep time, sleep efficiency, sleep fragmentation index, frequency of naps, and mean activity levelwill be completed for 3 - 2 week intervals by the subjects at home. Actigraphy measures will be collected at weeks 2, 4 and 6.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	MSLT and Polysomnograph (PSG) Testing Will be Compared.
Description	MSLT and PSG testing will take place prior to light intervention at screening 2 and post light intervention at week 4.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Bright White		Dim Red Light
Arm/Group Description	Bright white light treatment group. Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day.		Dim red light control group. Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using
All Cause Mortality
	Bright White		Dim Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bright White		Dim Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Bright White		Dim Red Light
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/13 (15.4%)		1/14 (7.1%)
Eye disorders
itchy eyes	0/13 (0%)	0	1/14 (7.1%)	1
Nervous system disorders
headache	1/13 (7.7%)	1	0/14 (0%)	0
sleepiness	1/13 (7.7%)	1	0/14 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.