Parkinson's DiseaseNCT02034357
Sleep Disordered Breathing and Its Impact on Neuro-cognitive Performance and Quality of Life in Parkinson Disease
A study testing Neurocognitive function and Sleep evaluations in people with Parkinson's Disease and Sleep Disordered Breathing, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of sleep and breathing problems during sleep on memory, attention, and general well being (quality of life) in people with Parkinson Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Sleep Disordered Breathing, Sleep Obstructive Apnea
- What is being tested?
- Neurocognitive function and Sleep evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give consent.
- ≥18 years and have a Hoehn and Yahr stage at the time of enrollment of ≤3, clinical diagnosis of idiopathic Parkinson's Disease meeting the United Kingdom Parkinson's Disease Society Brain Bank criteria.
- Stable medical condition, including medications in the 1 month prior to enrollment.
Who cannot join
- Previous diagnosis of SDB with active use of Positive Airway Pressure (PAP), surgery for SDB or tracheostomy.
- Inability to read and comprehend English and/or Spanish at a grade 5 level.
- Prior history of neurosurgical procedures for PD or any other condition.
- Diagnosis of dementia as defined by Mini-mental state examination (MMSE) of < 26.
- History of major uncontrolled psychiatric illness.
- History of drug or alcohol abuse/dependence.
- History of major head injury or other neurological disease.
- Patients with observable craniofacial abnormalities that may be a relative contraindication to PAP.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the impact of sleep and breathing problems during sleep on memory, attention, and general well being (quality of life) in people with Parkinson Disease.
Read the detailed description
During the 2 year award period, we will prospectively enroll 200 patients with idiopathic Parkinson Disease (PD), who meet eligibility criteria below. All patients will undergo a baseline polysomnography (PSG) to diagnose Sleep Disordered Breathing (SDB) and will be asked to complete validated questionnaires to measure Sleep Quality, SDB risk, insomnia severity, daytime sleepiness, presence of restless leg syndrome (RLS), anxiety/depression, and quality of life. Medical records will be reviewed to determine co-morbidities and medication use. Each PD participant will undergo a full neurological examination, including the Unified Parkinson's Disease Rating Scale (UPDRS), the Hoehn \& Yahr stage and a battery of neuro-cognitive measures at baseline. Patients with SDB will be offered PAP titration and treatment for 4 months. All patients (SDB [PAP compliant, non-compliant], and no SDB [controls]) will complete repeat neuro-cognitive evaluation, questionnaires, neurological evaluation and UPDRS assessment at 4 month and at 1 year follow-up. PD participants will be assessed in the "on" state in the morning. In the event that a participant goes "off" during testing, a break will be taken and participants will be given the option of taking their medication to return to the "on" state and resume testing or they can return later in the week to complete the evaluation. Although participants will understand the general purpose of the study, they will be blinded to the major study hypothesis. Neuropsychological examiners and the neurologist conducting the neurological exam will be blinded to the SDB status of the patient. Four month follow-up will be staggered according to enrolment date and will be completed by Year 2.
- Being tested
- Neurocognitive function, Sleep evaluations
- Keywords
- Parkinson Disease, Sleep Disordered Breathing, Sleep Obstructive Apnea, Polysomnography, CPAP (continuous positive airway pressure) titration, CPAP (continuous positive airway pressure) treatment
- Medical subject headings
- Parkinson Disease, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive functionOther
Each eligible participant will complete a neuro-cognitive assessment as measured by CVLT at the beginning of the study. Neurocognitive evaluations will be repeated at 4-month and 1-year follow-up.
Sleep evaluationsOther
Each eligible participant will complete sleep questionnaires and undergo a baseline sleep study at the beginning of the study. The sleep questionnaires will be repeated at 4-month and 1-year follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Neurocognitive function | Other | Neurocognitive function assessment (verbal learning and memory) as measured by CVLT and sleep evaluations in Parkinson's disease patients at baseline, and after 4 months and 1 year of CPAP treatment Receives: Other: Neurocognitive function; Other: Sleep evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Neurocognitive function in Parkinson's disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT)
Changes from Baseline Neurocognitive function (verbal learning and memory) in Parkinson's disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT).
Measured: Baseline, week 4, year 1
Secondary outcomes (3)
Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
Determine the Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
Measured: Baseline
Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
Measured: Baseline
Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startJun 2011
- Primary completionAug 2013
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation
- Responsible party
- Principal investigator, Carlos Singer, University of Miami
- Investigators
- Carlos Singer, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034357
- Sponsor's protocol ID
- 20110265
- Status last verified
- Mar 2016
- First submitted
- 15 Dec 2013
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shafazand S, Wallace DM, Arheart KL, Vargas S, Luca CC, Moore H, Katzen H, Levin B, Singer C. Insomnia, Sleep Quality, and Quality of Life in Mild to Moderate Parkinson's Disease. Ann Am Thorac Soc. 2017 Mar;14(3):412-419. doi: 10.1513/AnnalsATS.201608-625OC.
PubMed 28231027
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Its Impact on Neuro-cognitive Performance and Quality of Life in Parkinson Disease
- ClinicalTrials.gov ID
- NCT02034357
- Acronym / sponsor ID
- 20110265
- Keywords
- Parkinson Disease, Sleep Disordered Breathing, Sleep Obstructive Apnea, Polysomnography, CPAP (continuous positive airway pressure) titration, CPAP (continuous positive airway pressure) treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Parkinson Foundation
- Study start
- Jun 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 13 Jan 2014 (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.
The purpose of this study is to determine the impact of sleep and breathing problems during sleep on memory, attention, and general well being (quality of life) in people with Parkinson Disease.
Detailed description
During the 2 year award period, we will prospectively enroll 200 patients with idiopathic Parkinson Disease (PD), who meet eligibility criteria below. All patients will undergo a baseline polysomnography (PSG) to diagnose Sleep Disordered Breathing (SDB) and will be asked to complete validated questionnaires to measure Sleep Quality, SDB risk, insomnia severity, daytime sleepiness, presence of restless leg syndrome (RLS), anxiety/depression, and quality of life. Medical records will be reviewed to determine co-morbidities and medication use. Each PD participant will undergo a full neurological examination, including the Unified Parkinson's Disease Rating Scale (UPDRS), the Hoehn \& Yahr stage and a battery of neuro-cognitive measures at baseline. Patients with SDB will be offered PAP titration and treatment for 4 months. All patients (SDB [PAP compliant, non-compliant], and no SDB [controls]) will complete repeat neuro-cognitive evaluation, questionnaires, neurological evaluation and UPDRS assessment at 4 month and at 1 year follow-up. PD participants will be assessed in the "on" state in the morning. In the event that a participant goes "off" during testing, a break will be taken and participants will be given the option of taking their medication to return to the "on" state and resume testing or they can return later in the week to complete the evaluation. Although participants will understand the general purpose of the study, they will be blinded to the major study hypothesis. Neuropsychological examiners and the neurologist conducting the neurological exam will be blinded to the SDB status of the patient. Four month follow-up will be staggered according to enrolment date and will be completed by Year 2.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocognitive function | Other | Other: Neurocognitive function, Other: Sleep evaluationsNeurocognitive function assessment (verbal learning and memory) as measured by CVLT and sleep evaluations in Parkinson's disease patients at baseline, and after 4 months and 1 year of CPAP treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give consent.
- ≥18 years and have a Hoehn and Yahr stage at the time of enrollment of ≤3, clinical diagnosis of idiopathic Parkinson's Disease meeting the United Kingdom Parkinson's Disease Society Brain Bank criteria.
- Stable medical condition, including medications in the 1 month prior to enrollment.
Key exclusion criteria (8 listed)
- Previous diagnosis of SDB with active use of Positive Airway Pressure (PAP), surgery for SDB or tracheostomy.
- Inability to read and comprehend English and/or Spanish at a grade 5 level.
- Prior history of neurosurgical procedures for PD or any other condition.
- Diagnosis of dementia as defined by Mini-mental state examination (MMSE) of < 26.
- History of major uncontrolled psychiatric illness.
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 |
|---|---|---|
| Neurocognitive functionEach eligible participant will complete a neuro-cognitive assessment as measured by CVLT at the beginning of the study. Neurocognitive evaluations will be repeated at 4-month and 1-year follow-up. | Other | Neurocognitive function |
| Sleep evaluationsEach eligible participant will complete sleep questionnaires and undergo a baseline sleep study at the beginning of the study. The sleep questionnaires will be repeated at 4-month and 1-year follow-up. | Other | Neurocognitive function |
Primary outcome
Changes from Baseline Neurocognitive function in Parkinson's disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT)
Time frame: Baseline, week 4, year 1
Changes from Baseline Neurocognitive function (verbal learning and memory) in Parkinson's disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT).
3 secondary outcomes
Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.
Time frame: Baseline
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 24 Mar 2016.
- Derived from this study: PubMed 28231027Shafazand S, Wallace DM, Arheart KL, Vargas S, Luca CC, Moore H, Katzen H, Levin B, Singer C. Insomnia, Sleep Quality, and Quality of Life in Mild to Moderate Parkinson's Disease. Ann Am Thorac Soc. 2017 Mar;14(3):412-419. doi: 10.1513/AnnalsATS.201608-625OC.
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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.
Carlos Singer, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurocognitive function and Sleep evaluations in people with Parkinson's Disease and Sleep Disordered Breathing, run by University of Miami 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 3 inclusion and 8 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 24 Mar 2016. 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. 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?
Changes from Baseline Neurocognitive function in Parkinson's disease patients at 4 month and 1 year follow-up as measured by California Verbal Learning Test (CVLT) (time frame: Baseline, week 4, year 1). 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 NCT02034357, which also lists 1 linked publication.
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 24 Mar 2016.