Prostatic NeoplasmsNCT02919904
Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT
An observational study of Prostatic Neoplasms and Sleep, run by Vancouver Prostate Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms, Sleep
- What is being tested?
- ARESTM
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 25 men starting androgen deprivation therapy for asymptomatic prostate cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- ARESTM
- Keywords
- prostate cancer, sleep, androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARESTMDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Time taken to recruit men to this protocol will be measured
Measured: up to 2 years
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Prostate Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larry Goldenberg, MD, Principal investigator, University British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919904
- Sponsor's protocol ID
- Sleep Pilot
- Status last verified
- Oct 2019
- First submitted
- 6 Sep 2016
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02919904
- Acronym / sponsor ID
- Sleep Pilot
- Conditions
- Prostatic Neoplasms, Sleep
- Keywords
- prostate cancer, sleep, androgen deprivation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vancouver Prostate CentreUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 men starting androgen deprivation therapy for asymptomatic prostate cancer.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARESTMThe 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 | Device | – |
Primary outcome
Recruitment Rate
Time frame: up to 2 years
Time taken to recruit men to this protocol will be measured
4 secondary outcomes
Sleep quality parameters (composite outcome measure)
Time frame: At baseline, 3 months and 6 months
Pittsburgh Sleep Quality Index (PSQI): subjective sleep quality
Time frame: At baseline, 3 months and 6 months
Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: At baseline, 3 months and 6 months
Modified Expanded Prostate Cancer Index Composite (EPIC)
Time frame: At baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Goldenberg, MD principal investigator
University British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms and Sleep, run by Vancouver Prostate Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.