Feasibility of the Embr Thermal Device for Management of Hot Flashes in Men With Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Embr Labs, Inc.
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Embr thermal device usage, average number of sessions per day per participant
Study Overview
Brief Summary
This study is being conducted to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment.
Detailed Description
The Embr thermal device is a smart device that is worn on the inside of the wrist. It is about the size of a smart watch. The Embr thermal device produces cooling or warming temperature sensations that make some people feel slightly cooler or warmer. This objective of this study is to evaluate if the Embr thermal device is useful for men who experience bothersome hot flashes as a result of prostate cancer treatment. The study will take place over 4 weeks. The primary outcome is feasibility of the Embr thermal device in men with prostate cancer. Secondary outcomes include preliminary efficacy of the device, which will include the change in hot flash interference sleep measures (sleep impairment and fatigue). This is a remote study--all study assessments will be completed electronically.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have received a diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy or orchiectomy at least 1 month prior to enrollment.
- •May have received prior definitive radiation therapy or surgery (>60 days prior to study).
- •Have bothersome hot flashes (occurrence ≥ 28 times per week and at least moderately bothersome).
- •Presence of hot flashes for >30 days prior to study entry.
- •Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater).
- •Willing to downloading and use the Embr thermal device companion app on their phone
- •Willing to wear the Embr thermal device for 4 weeks, and charge and sync the device daily
- •In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English
Exclusion Criteria
- •Planned treatment with chemotherapy and/or any medical intervention that will impact hot flashes, sleep, or other daily activities of daily life during the 4-week study.
- •History of a known sleep disorder, other than insomnia (eg, obstructive sleep apnea, restless leg syndrome), or medical or psychiatric condition that affects sleep, or undergoing treatment for insomnia.
- •History of cognitive impairment or dysfunction.
- •Seizure history, history of recurrent falls, or known brain metastases.
- •Uncontrolled intercurrent illness.
- •Individuals with a second malignancy other than non-melanoma skin cancers.
- •Individuals taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior.
- •Individuals taking prescription sleep medications.
- •Individuals who report consuming more than 7 alcoholic beverages/week and/or frequent alcohol consumption within 2 hours prior to bed.
Outcomes
Primary Outcomes
Embr thermal device usage, average number of sessions per day per participant
Time Frame: Weeks 0 to 4
Number of sessions logged with the Embr device.
Embr thermal device usage, average number of minutes per day per participant
Time Frame: Weeks 0 to 4
Number of minutes logged with the Embr device.
Secondary Outcomes
- Epworth sleepiness scale, change in score(Week 0, 2, 4)
- PROMIS Sleep Disturbance short form 4a, change in score(Week 0, 2, 4)
- Hot Flash Related Daily Interference Scale (HFRDIS), change in score(Week 0, 2, 4)
- PROMIS Sleep-Related Impairment short form 8a, change in score(Weeks 0, 2, 4)