Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT

NCT02919904 | Completed

• 1 other identifier: Sleep Pilot
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms; Sleep

Keywords

prostate cancer; sleep; androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  Time taken to recruit men to this protocol will be measured

  up to 2 years

Secondary Outcomes (4)

• Sleep quality parameters (composite outcome measure)

  At baseline, 3 months and 6 months

• Pittsburgh Sleep Quality Index (PSQI): subjective sleep quality

  At baseline, 3 months and 6 months

• Hot Flash Related Daily Interference Scale (HFRDIS)

  At baseline, 3 months and 6 months

• Modified Expanded Prostate Cancer Index Composite (EPIC)

  At baseline, 3 months and 6 months

Interventions

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: * 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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

25 men starting androgen deprivation therapy for asymptomatic prostate cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vancouver Prostate Centre: lead

Study Sites (1)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Larry Goldenberg, MD

  University British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: September 29, 2016
• Study Start: July 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)