NCT02919904

Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT

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
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Vancouver Prostate Centre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostatic Neoplasms
• Sleep

Interventions

Type	Name	Description
DEVICE	ARESTM	The ARESTM device is a commercial home sleep-testing device that can record the following parameters (for up to 7 continuous hours) when participants are asleep: * NREM and REM sleep frequency and duration * Duration and number of arousal * Blood oxygen saturation and pulse rate via a silicone-embedded optical sensor * Fluctuation in nasal airflow pressure via a nasal cannula and pressure transducer * Head movement actigraphy and flux in snoring as measures of sleep/wake patterns via two accelerometers and an acoustic microphone * Apnea/hypopnea index and respiratory disturbance index

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-09-29
• Last updated: 2019-10-03

Locations

1 site across 1 country: Canada