RecruitingACTRN12612000699864

Treatment effectiveness, compliance and cardiovascular outcomes with a new supine avoidance therapy for supine-predominant snoring.

In snorers with supine-predominant snoring, is supine avoidance therapy an effective treatment with high patient compliance, and does the therapy improve cardiovascular outcomes?

Sponsor

A/Prof Peter Catcheside

Enrollment

40 participants

Start Date

Jul 2, 2012

Study Type

Interventional

Conditions

Snoring

Summary

This is a research study of a new treatment device designed to discourage snorers from sleeping on their back, when snoring is mainly a problem when asleep on the back. The hypotheses of this project are that by avoiding sleeping on their back, snorers would have (1) reduced frequency and intensity of snoring episodes, (2) reduced overnight cardiovascular system disturbances, and (3) lower daytime blood pressure.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a wearable device that stops snorers from sleeping on their back. Many people only snore (or snore much worse) when lying on their back. The device is designed to nudge the wearer into a side-sleeping position. The study measures whether this reduces snoring, improves heart function during sleep, and lowers daytime blood pressure. You may be eligible if: - You are 18 years or older - You snore mainly or only when sleeping on your back - A home sleep study has confirmed your snoring pattern - You do not have significant sleep apnea (fewer than 15 breathing pauses per hour) - Your bed partner is also willing to participate You may NOT be eligible if: - You have been diagnosed with obstructive sleep apnea (AHI 15 or above) - You have arthritis or mobility problems that prevent sleeping on your side - You have a pacemaker - You are dangerously sleepy (e.g., falling asleep while driving) - You are already being treated for high blood pressure Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Supine avoidance therapy using a body position monitoring and supine alarm device (BuzzPOD, Gorman ProMed Pty Ltd, VIC Australia). The study intervention is a small battery operated device worn on

Supine avoidance therapy using a body position monitoring and supine alarm device (BuzzPOD, Gorman ProMed Pty Ltd, VIC Australia). The study intervention is a small battery operated device worn on the chest each night. It records body position continuously and uses a vibration alarm activated after 5-sec in the supine position to discourage supine sleep. The device can be configured to record body position with or without supine alarm active, allowing long-term posture recordings with or without active therapy. An event button on the device is used to record bed-time and wake-up time to define periods of time in bed. Participants will be randomised to 2 weeks of inactive or alarm active therapy before crossing over to 2 weeks of the other condition (no washout). Posture recordings over the full trial period will be used to assess supine-avoidance effectiveness and device usage. In-home sleep studies and questionnaires at the end of each 2 week period will be used to assess other outcomes.