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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02727270
Other study ID # 15183
Secondary ID 3794533845467186
Status Completed
Phase
First received
Last updated
Start date June 2016
Est. completion date November 16, 2023

Study information

Verified date December 2023
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 131
Est. completion date November 16, 2023
Est. primary completion date November 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
No Intervention - Observational Study
No Intervention - Observational Study

Locations

Country Name City State
United States Oregon Health & Science Universtiy Portland Oregon
United States VA Portland Health Care System Portland Oregon

Sponsors (4)

Lead Sponsor Collaborator
Oregon Health and Science University Huntingtons Disease Society of America (HDSA), Oregon Clinical and Translational Research Institute, Portland VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ceravolo R, Frosini D, Poletti M, Kiferle L, Pagni C, Mazzucchi S, Volterrani D, Bonuccelli U. Mild affective symptoms in de novo Parkinson's disease patients: relationship with dopaminergic dysfunction. Eur J Neurol. 2013 Mar;20(3):480-485. doi: 10.1111/j.1468-1331.2012.03878.x. Epub 2012 Oct 18. — View Citation

Hartmann A, Veldhuis JD, Deuschle M, Standhardt H, Heuser I. Twenty-four hour cortisol release profiles in patients with Alzheimer's and Parkinson's disease compared to normal controls: ultradian secretory pulsatility and diurnal variation. Neurobiol Aging. 1997 May-Jun;18(3):285-9. doi: 10.1016/s0197-4580(97)80309-0. — View Citation

Marsden CD, Owen DA. Mechanisms underlying emotional variation in parkinsonian tremor. Neurology. 1967 Jul;17(7):711-5. doi: 10.1212/wnl.17.7.711. No abstract available. — View Citation

Matousek RH, Dobkin PL, Pruessner J. Cortisol as a marker for improvement in mindfulness-based stress reduction. Complement Ther Clin Pract. 2010 Feb;16(1):13-9. doi: 10.1016/j.ctcp.2009.06.004. Epub 2009 Jul 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Awakening Salivary Cortisol level (ug/dL) Response 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
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