Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT
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|ClinicalTrials.gov Identifier: NCT02919904|
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : October 3, 2019
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|Condition or disease||Intervention/treatment|
|Prostatic Neoplasms Sleep||Device: ARESTM|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|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|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
- 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
- Recruitment Rate [ Time Frame: up to 2 years ]Time taken to recruit men to this protocol will be measured
- Sleep quality parameters (composite outcome measure) [ Time Frame: At baseline, 3 months and 6 months ]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).
- Pittsburgh Sleep Quality Index (PSQI): subjective sleep quality [ Time Frame: At baseline, 3 months and 6 months ]To assess subjective sleep quality. This questionnaire will be administered at the same time points as the sleep recordings are carried out.
- Hot Flash Related Daily Interference Scale (HFRDIS) [ Time Frame: At baseline, 3 months and 6 months ]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.
- Modified Expanded Prostate Cancer Index Composite (EPIC) [ Time Frame: At baseline, 3 months and 6 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- Note: For participants who are having both hormone therapy and radiation, sleep parameters will only be measured before the participant starts radiation.
- Receiving antiandrogen monotherapy.
- Previous history of sleep disorder (e.g., being treated for obstructive sleep apnea (and wear a CPAP machine), narcolepsy, parasomnia, circadian rhythm abnormalities).
- Use of routine prescription or over the counter sleep medications (e.g., melatonin, zolpidem, suvorexant, eszopiclone, ramelteon, benzodiazepine, antihistamine).
- Active medical problems that interfere with sleep (e.g. congestive heart failure).
- Active medical problems that interfere with ARESTM reading or use of the device: deafness, blindness, severe arthritis, dementia, atrial fibrillation, tics or tremors of the head.
- Use of supplemental oxygen at night.
- Sensitivity of skin or scalp and/or open wounds on the forehead or scalp.
- Allergic reactions to extended exposure to synthetics fabrics (e.g. polyester, rayon).
- Upper respiratory infection or congestion.
- Inability to sleep at least 5 hours per night or a total of 8 hours over two nights.
- Inability to sleep with head reclined (less than 60 degree angle).
- Head circumference less than 21 inches or greater than 25 inches.
- Any reason that would prevent the participant from completing the study protocol or medical reason that would preclude them taking part.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919904
|Canada, British Columbia|
|Vancouver Prostate Centre|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||Larry Goldenberg, MD||University British Columbia|
|Responsible Party:||Vancouver Prostate Centre|
|Other Study ID Numbers:||
|First Posted:||September 29, 2016 Key Record Dates|
|Last Update Posted:||October 3, 2019|
|Last Verified:||October 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
androgen deprivation therapy
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Male Urogenital Diseases