NCT02034357

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

December 15, 2013

Last Update Submit

March 23, 2016

Conditions

Parkinson's DiseaseSleep Disordered BreathingSleep Obstructive Apnea

Keywords

Parkinson DiseaseSleep Disordered BreathingSleep Obstructive ApneaPolysomnographyCPAP (continuous positive airway pressure) titrationCPAP (continuous positive airway pressure) treatment

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, week 4, year 1

Secondary Outcomes (3)

  • Prevalence of Sleep Disordered Breathing (SDB) in a diverse cohort of idiopathic PD patients.

    Baseline

  • Prevalence of Insomnia in a diverse cohort of idiopathic PD patients.

    Baseline

  • Prevalence of Poor Sleep Quality in a diverse cohort of idiopathic PD patients.

    Baseline

Study Arms (1)

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

Other: Neurocognitive functionOther: Sleep evaluations

Interventions

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.

Neurocognitive function
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.

Neurocognitive function

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

  • 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.

    PMID: 28231027DERIVED

MeSH Terms

Conditions

Parkinson DiseaseSleep Apnea SyndromesSleep Apnea, ObstructiveMicrocephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • Carlos Singer, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Chief Parkinson Disease and Movement Disorders

Study Record Dates

First Submitted

December 15, 2013

First Posted

January 13, 2014

Study Start

June 1, 2011

Primary Completion

August 1, 2013

Study Completion

March 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

US(1)