Measuring Cortisol Levels in Persons With Parkinson's (PD) (CORT-PD)

December 16, 2023 updated by: Amie Hiller, MD, Oregon Health and Science University
The objective of this study is to evaluate the cortisol awakening response with persons with Parkinsons Disease (PD), Huntingtons Disease (HD), and controls. These data are desired so experience can be gained with measuring stress levels subjectively and objectively in persons with PD, HD, and controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Telephone consent will be obtained.

Participants will collect saliva at twelve time points - four times a day for three days.

Visits will be conducted virtually (over the internet).

The virtual visit is to assess Parkinson's or Huntington's disease status, stress, mood, and quality of life.

Study Type

Observational

Enrollment (Actual)

131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Brenna M Lobb, MS, MPH
  • Phone Number: 51871 503.220.8262
  • Email: lobbb@ohsu.edu

Study Contact Backup

  • Name: Susan M O'Connor, RN
  • Phone Number: 51091 503.220.8262

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The investigators plan to enroll seven groups: (1) person with PD and moderate levels of self-reported stress, (2) persons with PD and low levels of self-reported stress, (3) controls and moderate levels of self-reported stress, (4) controls and low levels of self-reported stress, (5) persons with HD and moderate/high levels of self-reported stress, and (6) persons with HD a low levels of self-reported stress, and (7) those that completed the study prior to COVID-19 restrictions in March of 2020.

Description

Inclusion Criteria:

Group (3) Inclusion:

  • No significant neurological disorder
  • PSS score of greater than or equal to 13.

Group (5) Inclusion:

  • HD diagnosis or HD gene carrier
  • a Perceived Stress Scale (PSS) score higher than or equal to 13.

Group (6) Inclusion:

  • HD diagnosis or HD gene carrier
  • PSS score lower than 13

Group (7) Inclusion:

  • PD diagnosis
  • Prior completion of the study.

Exclusion Criteria:

  • The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson's - High Stress *FULL NOT RECRUITING
Parkinson's disease patients with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Parkinson's - Low Stress *FULL NOT RECRUITING
Parkinson's disease patients with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Controls - Low Stress *FULL NOT RECRUITING
Healthy controls (no neurological disease) with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Controls - High Stress *FULL NOT RECRUITING
Healthy controls (no neurological disease) with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Huntington's - High Stress *FULL NOT RECRUITING
Huntington's disease patients and/or Huntington's disease gene carriers with self-reported high strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Huntington's - Low Stress *FULL NOT RECRUITING
Huntington's disease patients and/or Huntington's disease gene carriers with self-reported low strain/stress.
Other: No Intervention - Observational Study
No Intervention - Observational Study
Parkinson's Disease - ReEnrollment (COVID-19) *FULL NOT RECRUITING
Parkinson's disease patients that had previously completed the study.
Other: No Intervention - Observational Study
No Intervention - Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Awakening Salivary Cortisol level (ug/dL) Response
Time Frame: Collected upon awakening and 30 minutes after awakening
Salivary Cortisol level (ug/dL) Response is the change in cortisol between awakening and 30 minutes after awakening.
Collected upon awakening and 30 minutes after awakening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

Oregon Clinical and Translational Research Institute
Portland VA Medical Center
Huntingtons Disease Society of America (HDSA)

Investigators

  • Principal Investigator: Amie L Hiller, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

November 16, 2023

Study Completion (Actual)

November 16, 2023

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimated)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 16, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15183
  • 3794 (Other Identifier: VA Portland Health Care System)
  • 5338 (Other Identifier: Oregon Clinical Translational Research Institute)
  • 4546 (Other Identifier: VA Portland Health Care System)
  • 7186 (Other Identifier: Oregon Clinical Translational Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data be available (including data dictionaries). Individual participant data that underlie the results reported the resultant article, after deidentification (text, tables, figures, and appendices). In addition to data, the study protocol and the informed consent form (ICF) will be provided. Data will be available beginning 6 months and ending 2 years following article publication.

IPD Sharing Time Frame

6 months - 2 years following article publication

IPD Sharing Access Criteria

Data will be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Data will be released to achieve aims in the approved proposal or for individual participant data meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on No Intervention - Observational Study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe