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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARESTM | Device | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rate | Time taken to recruit men to this protocol will be measured | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep quality parameters (composite outcome measure) | To measure parameters associated with sleep quality (non-rapid eye movement (NREM) & and rapid eye movement (REM), sleep frequency and duration, duration and number of awakenings, blood oxygen saturation and pulse rate, fluctuation in nasal airflow pressure, head movement actigraphy and flux in snoring as measures of sleep/wake patterns, apnea/hypopnea index and respiratory disturbance index). |
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Inclusion Criteria:
Newly diagnosed prostate cancer starting hormone therapy with or without concomitant radiation therapy for at least 6 months, or
Biochemical relapse of prostate cancer without metastatic symptoms (i.e. rising Prostate-specific antigen (PSA) after definitive therapy with no evidence of metastatic disease)*.
Serum testosterone in the hypogonadal range or above, but not at castrate levels.
About to start ADT with a Luteinizing Hormone-Releasing Hormone (LHRH) analogue for at least 6 months.
Fluent in English (able to read, write, and speak in English).
Provide written informed consent.
Patients with sleep apnea who do not depend on a CPAP (continuous positive airway pressure) machine to sleep may join the study.
Exclusion Criteria:
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25 men starting androgen deprivation therapy for asymptomatic prostate cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Larry Goldenberg, MD | University British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Prostate Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| At baseline, 3 months and 6 months |
| Pittsburgh Sleep Quality Index (PSQI): subjective sleep quality | To assess subjective sleep quality. This questionnaire will be administered at the same time points as the sleep recordings are carried out. | At baseline, 3 months and 6 months |
| Hot Flash Related Daily Interference Scale (HFRDIS) | To assess whether severe hot flash interferes with various daily activities. This questionnaire will be administered at the same time points as the sleep recordings are carried out. | At baseline, 3 months and 6 months |
| Modified Expanded Prostate Cancer Index Composite (EPIC) | To assess study participant's urinary symptoms, frequency and how bothered they are with some ADT side effects (e.g. depression, fatigue, weight gain). This questionnaire will be administered at the same time points as the sleep recordings are carried out. | At baseline, 3 months and 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |