Personalized Sound Frequency Therapy for Adults With Insomnia and Sleep Disturbance A 12-Week Polysomnography Study to Improve Sleep Quality and Architecture

What this Trial Is About

Insomnia is a common sleep disorder marked by ongoing difficulties falling or staying asleep, often leading to daytime problems. It affects about 10-15% of adults and can have serious physical, mental, and social impacts. This research evaluates personalized nocturnal sound frequency therapy, a non-drug approach designed to improve brain rhythms during sleep, aiming to enhance sleep quality and architecture in people with insomnia. Participants will use a wearable sound stimulation device for 12 weeks. This device delivers personalized low-frequency sounds, such as pink noise or slow-wave-matched tones, twice daily for one hour each session once in the morning upon waking and once in the evening before sleep. The therapy is self-administered at home with volume above 30% and frequencies between 15 and 20,000 Hz. The study includes baseline and follow-up overnight sleep studies polysomnography to measure effects. During the study, participants will undergo sleep assessments including polysomnography to evaluate sleep stages and quality before and after treatment. Questionnaires measuring insomnia severity, sleep quality, and daytime sleepiness will also be completed. Researchers will monitor treatment adherence, tolerability, and any adverse events over the 12 weeks. The primary outcome is to compare sleep architecture changes, with secondary outcomes including changes in insomnia severity, sleep quality, daytime sleepiness, and apnea-hypopnea index.

Sleep Optimization With Acoustic Therapy