Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-05 @ 5:17 PM
Study NCT ID:
NCT02919904
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2016-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2016-09-06', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Rate', 'timeFrame': 'up to 2 years', 'description': 'Time taken to recruit men to this protocol will be measured'}], 'secondaryOutcomes': [{'measure': 'Sleep quality parameters (composite outcome measure)', 'timeFrame': 'At baseline, 3 months and 6 months', 'description': '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).'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI): subjective sleep quality', 'timeFrame': 'At baseline, 3 months and 6 months', 'description': 'To assess subjective sleep quality. This questionnaire will be administered at the same time points as the sleep recordings are carried out.'}, {'measure': 'Hot Flash Related Daily Interference Scale (HFRDIS)', 'timeFrame': 'At baseline, 3 months and 6 months', 'description': '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.'}, {'measure': 'Modified Expanded Prostate Cancer Index Composite (EPIC)', 'timeFrame': 'At baseline, 3 months and 6 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'sleep', 'androgen deprivation therapy'], 'conditions': ['Prostatic Neoplasms', 'Sleep']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 men starting androgen deprivation therapy for asymptomatic prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed prostate cancer starting hormone therapy with or without concomitant radiation therapy for at least 6 months, or\n2. Biochemical relapse of prostate cancer without metastatic symptoms (i.e. rising Prostate-specific antigen (PSA) after definitive therapy with no evidence of metastatic disease)\\*.\n3. Serum testosterone in the hypogonadal range or above, but not at castrate levels.\n4. About to start ADT with a Luteinizing Hormone-Releasing Hormone (LHRH) analogue for at least 6 months.\n5. Fluent in English (able to read, write, and speak in English).\n6. Provide written informed consent.\n7. Patients with sleep apnea who do not depend on a CPAP (continuous positive airway pressure) machine to sleep may join the study.\n\n * Note: For participants who are having both hormone therapy and radiation, sleep parameters will only be measured before the participant starts radiation.\n\nExclusion Criteria:\n\n1. Receiving antiandrogen monotherapy.\n2. Previous history of sleep disorder (e.g., being treated for obstructive sleep apnea (and wear a CPAP machine), narcolepsy, parasomnia, circadian rhythm abnormalities).\n3. Use of routine prescription or over the counter sleep medications (e.g., melatonin, zolpidem, suvorexant, eszopiclone, ramelteon, benzodiazepine, antihistamine).\n4. Active medical problems that interfere with sleep (e.g. congestive heart failure).\n5. 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.\n6. Use of supplemental oxygen at night.\n7. Sensitivity of skin or scalp and/or open wounds on the forehead or scalp.\n8. Allergic reactions to extended exposure to synthetics fabrics (e.g. polyester, rayon).\n9. Upper respiratory infection or congestion.\n10. Inability to sleep at least 5 hours per night or a total of 8 hours over two nights.\n11. Inability to sleep with head reclined (less than 60 degree angle).\n12. Head circumference less than 21 inches or greater than 25 inches.\n13. Any reason that would prevent the participant from completing the study protocol or medical reason that would preclude them taking part.'}, 'identificationModule': {'nctId': 'NCT02919904', 'briefTitle': 'Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT', 'organization': {'class': 'OTHER', 'fullName': 'Vancouver Prostate Centre'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Sleep Pilot'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARESTM', 'type': 'DEVICE', 'description': '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:\n\n* NREM and REM sleep frequency and duration\n* Duration and number of arousal\n* Blood oxygen saturation and pulse rate via a silicone-embedded optical sensor\n* Fluctuation in nasal airflow pressure via a nasal cannula and pressure transducer\n* Head movement actigraphy and flux in snoring as measures of sleep/wake patterns via two accelerometers and an acoustic microphone\n* Apnea/hypopnea index and respiratory disturbance index'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver Prostate Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Larry Goldenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vancouver Prostate Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}