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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 : Recruiting
First Posted : September 29, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Larry Goldenberg, MD, Vancouver Prostate Centre

Brief 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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Sleep Device: ARESTM

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 Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • 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


Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: up to 2 years ]
    Time taken to recruit men to this protocol will be measured


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



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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
Study Population
25 men starting androgen deprivation therapy for asymptomatic prostate cancer.
Criteria

Inclusion Criteria:

  1. Newly diagnosed prostate cancer starting hormone therapy with or without concomitant radiation therapy for at least 6 months, or
  2. Biochemical relapse of prostate cancer without metastatic symptoms (i.e. rising Prostate-specific antigen (PSA) after definitive therapy with no evidence of metastatic disease)*.
  3. Serum testosterone in the hypogonadal range or above, but not at castrate levels.
  4. About to start ADT with a Luteinizing Hormone-Releasing Hormone (LHRH) analogue for at least 6 months.
  5. Fluent in English (able to read, write, and speak in English).
  6. Provide written informed consent.
  7. 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.

Exclusion Criteria:

  1. Receiving antiandrogen monotherapy.
  2. Previous history of sleep disorder (e.g., being treated for obstructive sleep apnea (and wear a CPAP machine), narcolepsy, parasomnia, circadian rhythm abnormalities).
  3. Use of routine prescription or over the counter sleep medications (e.g., melatonin, zolpidem, suvorexant, eszopiclone, ramelteon, benzodiazepine, antihistamine).
  4. Active medical problems that interfere with sleep (e.g. congestive heart failure).
  5. 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.
  6. Use of supplemental oxygen at night.
  7. Sensitivity of skin or scalp and/or open wounds on the forehead or scalp.
  8. Allergic reactions to extended exposure to synthetics fabrics (e.g. polyester, rayon).
  9. Upper respiratory infection or congestion.
  10. Inability to sleep at least 5 hours per night or a total of 8 hours over two nights.
  11. Inability to sleep with head reclined (less than 60 degree angle).
  12. Head circumference less than 21 inches or greater than 25 inches.
  13. Any reason that would prevent the participant from completing the study protocol or medical reason that would preclude them taking part.

Information from the National Library of Medicine

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


Contacts
Contact: Olga Arsovska, MSc 6048754111 ext 62338 oarsovska@prostatecentre.com
Contact: Phil Pollock, MRes 6048754111 ext 22946 ppollock@prostatecentre.com

Locations
Canada, British Columbia
Vancouver Prostate Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Martin Gleave, MD         
Contact: Larry Goldenberg, MD         
Sponsors and Collaborators
Vancouver Prostate Centre
Investigators
Principal Investigator: Larry Goldenberg, MD University British Columbia

Responsible Party: Larry Goldenberg, MD, Principal Investigator, Vancouver Prostate Centre
ClinicalTrials.gov Identifier: NCT02919904     History of Changes
Other Study ID Numbers: Sleep Pilot
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Goldenberg, MD, Vancouver Prostate Centre:
prostate cancer
sleep
androgen deprivation therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs