Parkinson's DiseaseNCT01338649

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

A study testing Bright Light Treatment (Sun Ray Sunbox SB-558) and Dim red light (Sun Ray Sunbox SB-558) in people with Parkinson's Disease and Sleep Disorder; Excessive Somnolence, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: Parkinson's Disease, Sleep Disorder; Excessive Somnolence
What is being tested?: Bright Light Treatment (Sun Ray Sunbox SB-558) and Dim red light (Sun Ray Sunbox SB-558)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Oct 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria
Hoehn and Yahr stage of 2 to 4 in the "on" state
Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points
Stable PD medication regimen for at least 4 weeks prior to study screening
Willing and able to give written informed consent

Who cannot join

Atypical parkinsonian syndromes
Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)
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)
Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
Presence of depression defined as the Beck Depression Inventory (BDI) score >14
Untreated hallucinations or psychosis (drug-induced or spontaneous)

Show all 10Show fewer

Use of hypno-sedative drugs for sleep or stimulants during the daytime
Use of antidepressants unless the patient has been on a stable dose for at least three months
Visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness
Travel through 2 time zones within 90 days prior to study screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease

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.

Read the detailed description

See above.

Conditions: Parkinson's Disease, Sleep Disorder; Excessive Somnolence
Being tested: Bright Light Treatment (Sun Ray Sunbox SB-558), Dim red light (Sun Ray Sunbox SB-558)
Keywords: Parkinson's disease, Daytime somnolence, Sleepiness, Light therapy
Medical subject headings: Parkinson Disease, Sleep Wake Disorders, Disorders of Excessive Somnolence, Sleepiness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bright Light Treatment (Sun Ray Sunbox SB-558)Device
Also called 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.
Dim red light (Sun Ray Sunbox SB-558)Device
Also called Sun Ray Sunbox SB-558
Dim red light box administered during two 1 hour periods during the day using

Study groups in NCT01338649
Study group	Role	What they receive
Bright White	Active comparator	Exposure to bright white light treatment. Receives: Device: Bright Light Treatment (Sun Ray Sunbox SB-558)
Dim red light	Placebo comparator	Exposure to dim red light treatment. Receives: Device: Dim red light (Sun Ray Sunbox SB-558)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Oct 2012

First posted19 Apr 2011 (estimated)
Study startNov 2007
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01338649
Sponsor's protocol ID: Light Therapy in PD
Status last verified: Feb 2023
First submitted: 18 Apr 2011
Last updated: 1 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Lees AJ, Blackburn NA, Campbell VL. The nighttime problems of Parkinson's disease. Clin Neuropharmacol. 1988 Dec;11(6):512-9. doi: 10.1097/00002826-198812000-00004.
PubMed 3233589
Tandberg E, Larsen JP, Karlsen K. A community-based study of sleep disorders in patients with Parkinson's disease. Mov Disord. 1998 Nov;13(6):895-9. doi: 10.1002/mds.870130606.
PubMed 9827612
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. doi: 10.1136/jnnp.69.5.584.
PubMed 11032608
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. doi: 10.1007/s10072-003-0134-y.
PubMed 14598091
Meindorfner C, Korner Y, Moller JC, Stiasny-Kolster K, Oertel WH, Kruger HP. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005 Jul;20(7):832-42. doi: 10.1002/mds.20412.
PubMed 15726539
Factor SA, McAlarney T, Sanchez-Ramos JR, Weiner WJ. Sleep disorders and sleep effect in Parkinson's disease. Mov Disord. 1990;5(4):280-5. doi: 10.1002/mds.870050404.
PubMed 2259351
Stocchi F, Barbato L, Nordera G, Berardelli A, Ruggieri S. Sleep disorders in Parkinson's disease. J Neurol. 1998 May;245 Suppl 1:S15-8. doi: 10.1007/pl00007731.
PubMed 9617717
Paus S, Brecht HM, Koster J, Seeger G, Klockgether T, Wullner U. Sleep attacks, daytime sleepiness, and dopamine agonists in Parkinson's disease. Mov Disord. 2003 Jun;18(6):659-67. doi: 10.1002/mds.10417.
PubMed 12784269
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. doi: 10.1046/j.1365-2869.2000.00201.x.
PubMed 10733691
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. doi: 10.1210/jcem.82.11.4355.
PubMed 9360538
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. doi: 10.1016/0149-7634(95)00018-6.
PubMed 8684716
Moore RY, Eichler VB. Loss of a circadian adrenal corticosterone rhythm following suprachiasmatic lesions in the rat. Brain Res. 1972 Jul 13;42(1):201-6. doi: 10.1016/0006-8993(72)90054-6. No abstract available.
PubMed 5047187
Dijk DJ, Lockley SW; New Collective Author. Integration of human sleep-wake regulation and circadian rhythmicity. J Appl Physiol (1985). 2002 Feb;92(2):852-62. doi: 10.1152/japplphysiol.00924.2001.
PubMed 11796701
Moore-Ede MC, Czeisler CA, Richardson GS. Circadian timekeeping in health and disease. Part 2. Clinical implications of circadian rhythmicity. N Engl J Med. 1983 Sep 1;309(9):530-6. doi: 10.1056/NEJM198309013090905. No abstract available.
PubMed 6348546
Czeisler CA, Allan JS, Strogatz SH, Ronda JM, Sanchez R, Rios 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. doi: 10.1126/science.3726555.
PubMed 3726555

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Bright Light Treatment on Daytime Sleepiness and Nocturnal Sleep in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT01338649
Acronym / sponsor ID: Light Therapy in PD
Conditions: Parkinson's Disease, Sleep Disorder; Excessive Somnolence
Keywords: Parkinson's disease, Daytime somnolence, Sleepiness, Light therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Parkinson Foundation
Study start: Nov 2007
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 19 Apr 2011 (estimated)
Results: Posted 5 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

See above.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Bright White	Active comparator	Device: Bright Light Treatment (Sun Ray Sunbox SB-558)Exposure to bright white light treatment.
Dim red light	Placebo comparator	Device: Dim red light (Sun Ray Sunbox SB-558)Exposure to dim red light treatment.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of idiopathic PD as defined by the United Kingdom Parkinson's Disease Society Brain Bank Criteria
Hoehn and Yahr stage of 2 to 4 in the "on" state
Excessive daytime sleepiness as defined by the Epworth Sleepiness Scale (ESS) score of greater than or equal to 12 points
Stable PD medication regimen for at least 4 weeks prior to study screening
Willing and able to give written informed consent

Key exclusion criteria (10 listed)

Atypical parkinsonian syndromes
Significant sleep disordered breathing (defined as an apnea-hypopnea index >15 events/hr of sleep on screening PSG)
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)
Cognitive impairment indicated by the mini-mental status examination (MMSE) score of less than 24
Presence of depression defined as the Beck Depression Inventory (BDI) score >14

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bright Light Treatment (Sun Ray Sunbox SB-558)Also: Sun Ray Sunbox SB-558Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.	Device	Bright White
Dim red light (Sun Ray Sunbox SB-558)Also: Sun Ray Sunbox SB-558Dim red light box administered during two 1 hour periods during the day using	Device	Dim red light

Primary outcome

Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.
Time frame: 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.

Results and safety

Results posted to the registry on 5 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bright White	13	13
Dim Red Light	14	14

Primary outcome: Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure.

Time frame: baseline and 4 weeks. Mean (Standard Deviation). Unit: score

Measure	Bright White n = 13	Dim Red Light n = 14
Value	4.46 (2.54)	1.77 (3)

Bright White vs Dim Red Light: p = 0.0211, t-test, 2 sided

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bright White	0 of 13 (0%)	2 of 13 (15.4%)	Not reported
Dim Red Light	0 of 14 (0%)	1 of 14 (7.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3233589Lees AJ, Blackburn NA, Campbell VL. The nighttime problems of Parkinson's disease. Clin Neuropharmacol. 1988 Dec;11(6):512-9. doi: 10.1097/00002826-198812000-00004.
Background: PubMed 9827612Tandberg E, Larsen JP, Karlsen K. A community-based study of sleep disorders in patients with Parkinson's disease. Mov Disord. 1998 Nov;13(6):895-9. doi: 10.1002/mds.870130606.
Background: PubMed 11032608Karlsen 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. doi: 10.1136/jnnp.69.5.584.
Background: PubMed 14598091Scaravilli 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. doi: 10.1007/s10072-003-0134-y.
Background: PubMed 15726539Meindorfner C, Korner Y, Moller JC, Stiasny-Kolster K, Oertel WH, Kruger HP. Driving in Parkinson's disease: mobility, accidents, and sudden onset of sleep at the wheel. Mov Disord. 2005 Jul;20(7):832-42. doi: 10.1002/mds.20412.
Background: PubMed 2259351Factor SA, McAlarney T, Sanchez-Ramos JR, Weiner WJ. Sleep disorders and sleep effect in Parkinson's disease. Mov Disord. 1990;5(4):280-5. doi: 10.1002/mds.870050404.
Background: PubMed 9617717Stocchi F, Barbato L, Nordera G, Berardelli A, Ruggieri S. Sleep disorders in Parkinson's disease. J Neurol. 1998 May;245 Suppl 1:S15-8. doi: 10.1007/pl00007731.
Background: PubMed 12784269Paus S, Brecht HM, Koster J, Seeger G, Klockgether T, Wullner U. Sleep attacks, daytime sleepiness, and dopamine agonists in Parkinson's disease. Mov Disord. 2003 Jun;18(6):659-67. doi: 10.1002/mds.10417.
Background: PubMed 10733691Rye DB, Bliwise DL, Dihenia B, Gurecki P. FAST TRACK: daytime sleepiness in Parkinson's disease. J Sleep Res. 2000 Mar;9(1):63-9. doi: 10.1046/j.1365-2869.2000.00201.x.
Background: PubMed 9360538Lockley 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. doi: 10.1210/jcem.82.11.4355.
Background: PubMed 8684716Myers BL, Badia P. Changes in circadian rhythms and sleep quality with aging: mechanisms and interventions. Neurosci Biobehav Rev. 1995 Winter;19(4):553-71. doi: 10.1016/0149-7634(95)00018-6.
Background: PubMed 5047187Moore RY, Eichler VB. Loss of a circadian adrenal corticosterone rhythm following suprachiasmatic lesions in the rat. Brain Res. 1972 Jul 13;42(1):201-6. doi: 10.1016/0006-8993(72)90054-6. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aleksandar Videnovic, MD, MS principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Epworth Sleepiness Scale (ESS) Scores Comparing the Bright Light Exposure With Dim-red Light Exposure. (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338649, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.