Parkinson's DiseaseNCT01742182

Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease

A study testing Light exposure in people with Parkinson's Disease, run by Massachusetts General Hospital 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

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Trial summary

Who is it for?: Ages 55 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: Light exposure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

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 55 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
PD Hoehn and Yahr stage 2-4;
Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and <10 in group 2;
Control participants will be matched for gender and age with PD participants.

Who cannot join

Atypical or secondary forms of Parkinsonism;
Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;
Use of medications known to affect melatonin secretion;
Unstable/serious medical illness.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients and healthy controls. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Conditions: Parkinson's Disease
Being tested: Light exposure
Keywords: Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
Medical subject headings: Parkinson Disease, Disorders of Excessive Somnolence

What participants receive

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

Light exposureOther

Study groups in NCT01742182
Study group	Role	What they receive
Control	No intervention	Not described
PD patients without sleep problems	No intervention	Not described
PD patients with sleep problems	Active comparator	light exposure Receives: Other: Light exposure
PD patients with sleep problem	Placebo comparator	light exposure Receives: Other: Light exposure

What is being measured

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

circadian rhythm of melatonin
Measured: June 2012- May 2017
Sleep Efficiency
Measured: June 2012- May 2017
Daytime Somnolence
Measured: June 2012- May 2017

Timeline

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

Jun 2012Jun 2018

First posted5 Dec 2012 (estimated)
Study startJun 2012
Primary completionJun 2018
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01742182
Sponsor's protocol ID: Circadian Rhythms in PD
Other IDs: 1K23NS072283-01A1
Status last verified: Feb 2020
First submitted: 3 Dec 2012
Last updated: 18 Feb 2020
Results posted: No
Data monitoring committee: No

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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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Circadian Rhythms and Sleep-Wake Cycles in Parkinson's Disease
ClinicalTrials.gov ID: NCT01742182
Acronym / sponsor ID: Circadian Rhythms in PD
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease, Excessive Daytime Sleepiness, Circadian Rhythms, Light Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Jun 2012 (actual)
Primary completion: Jun 2018 (actual)
Study completion: Jun 2018 (actual)
First posted: 5 Dec 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Control	No intervention	–
PD patients without sleep problems	No intervention	–
PD patients with sleep problems	Active comparator	Other: Light exposurelight exposure
PD patients with sleep problem	Placebo comparator	Other: Light exposurelight exposure

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria;
PD Hoehn and Yahr stage 2-4;
Pittsburgh Sleep Quality Index (PSQI) score >5 in group 1, and ≤5 in group 2;
Epworth Sleepiness Scale (ESS) score ≥10 in group 1, and <10 in group 2;
Control participants will be matched for gender and age with PD participants.

Key exclusion criteria (7 listed)

Atypical or secondary forms of Parkinsonism;
Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26;
Presence of depression defined as the Beck Depression Inventory (BDI) score >14;
Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible at least 4 weeks after the taper is completed;
Use of SSRIs / SNRIs antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening;

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
Light exposure	Other	PD patients with sleep problem, PD patients with sleep problems

Primary outcome

circadian rhythm of melatonin
Time frame: June 2012- May 2017
Sleep Efficiency
Time frame: June 2012- May 2017
Daytime Somnolence
Time frame: June 2012- May 2017

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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 principal investigator

Massachusetts General Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Light exposure in people with Parkinson's Disease, run by Massachusetts General Hospital at 1 site in United States.

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 7 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 18 Feb 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

circadian rhythm of melatonin (time frame: June 2012- May 2017). The study lists 3 primary outcomes in all. 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 NCT01742182.

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 18 Feb 2020.