Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT02919904
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2016-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT
Sponsor:
Vancouver Prostate Centre
Organization:
Study Overview
Official Title:
Feasibility of Using the ARESTM Device to Measure Sleep Parameters in Men With Asymptomatic Prostate Cancer Before as Well as at 3 and 6 Months After Starting Androgen Deprivation Therapy
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The feasibility of using the Apnea Risk Evaluating System (ARESTM) device to take longitudinal measures of sleep parameters in asymptomatic men with prostate cancer who are about to initiate androgen deprivation therapy (ADT) will be evaluated. Study participants will complete serial questionnaires relating to sleep quality, hot flashes, and quality of life.
Detailed Description:
The primary purpose of our study is to examine the feasibility of using the ARESTM device to measure sleep parameters of prostate cancer patients who are beginning ADT. Although some evidence links ADT to poor quality of sleep, no research has assessed the impact of ADT on most sleep parameters. We chose the ARESTM device for this study because the device can comprehensively measure sleep parameters. Furthermore, unlike polysomnography, the ARESTM device is easy to use and the measurements can be done at participants' home, without requiring them to adapt to a new sleeping location (e.g., sleep lab). ARESTM is a wireless device that is worn on the forehead during sleep to record physiological parameters. In addition, the feasibility of obtaining serial questionnaires from patients will be assessed. In this pilot study, the study investigators will attempt to make some preliminary correlations between sleep quality (as measured by ARESTM) with subjective sleep quality, morphometric measures, urinary symptoms, and hot flashes. Data collected from this study will help to determine the acceptability of and compliance with using the ARESTM device by this patient population.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: