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

Completed

• Conditions: Parkinson Disease; Huntington Disease
• Interventions: Other: No Intervention - Observational Study

• Registration Number: NCT02727270
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-29
• Study First Posted: 2016-04-04
• Study Start: 2016-06
• Primary Completion: 2023-11-16
• Study Completion: 2023-11-16
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-16
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Awakening Salivary Cortisol level (ug/dL) Response	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.

Trial Locations

Locations (2)

Oregon Health & Science Universtiy; 🇺🇸 Portland, Oregon, United States

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States