Clinical trial · Observational
Feasibility Study for the Assessment of Sleep Quality in Men With Prostate Cancer Starting ADT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
| Sleep | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARESTM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recruitment Rate
- timeFrame
- up to 2 years
- description
- Time taken to recruit men to this protocol will be measured
Secondary outcomes (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available