None listed
Conditions
Brief summary
Obstructive Sleep Apnoea (OSA) is a chronic disorder caused by repetitive upper airway collapse during sleep. One aspect of sleep that is critical for effective cognition is the presence of slow wave sleep; a deep, stable phase of Non-REM sleep. It has been found that that individuals with OSA have less slow wave sleep, poorer cognition and brain atrophy compared to healthy individuals. Existing treatments for OSA have a limited impact on cognition and patient acceptance is poor. Direct enhancement of slow wave activity via acoustic stimulation is a new, non-invasive therapy for improving sleep quality and cognition. Preliminary work showed acoustic stimulation in healthy adults enhanced SWA, improved cognition and reduced next-day sleepiness. The current project will test the hypotheses that acoustic stimulation increases SWA, alters OSA pathophysiology, improves cognition, and reduces sleepiness in individuals with OSA.
Interventions
This study will be a cross over trial, with a 7 day wash out period between the experimental condition and the control condition. It will be delivered in person and individually in a controlled sleep laboratory by sleep study technicians. Participants will undergo a two night in-laboratory stay at the Monash Sleep and Circadian Medicine Laboratory at the Be Active Sleep Eat (BASE) facility where they will use the Sleep Loop acoustic stimulation during their sleep for both nights. The Sleep Loop
This study will be a cross over trial, with a 7 day wash out period between the experimental condition and the control condition. It will be delivered in person and individually in a controlled sleep laboratory by sleep study technicians. Participants will undergo a two night in-laboratory stay at the Monash Sleep and Circadian Medicine Laboratory at the Be Active Sleep Eat (BASE) facility where they will use the Sleep Loop acoustic stimulation during their sleep for both nights. The Sleep Loop device will administer pulses of auditory tones via earphones that are precisely timed to the slow wave activity during stage 3 sleep, which help strengthen and increase its amplitude. The experimental condition (STIM) will utilise a windowed approach where stimulations will be enabled for an interval of 6 seconds (ON window) and immediately thereafter disabled for another 6 seconds (OFF window). To avoid waking participants due to the auditory stimuli, the volume of the stimuli will be adapted to the depth of sleep and stimulus related to detected arousal.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
35 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Apnea-Hypopnea Index (AHI) >5 events/hr (determined by overnight sleep study) Aged 35-50 years Diagnosis of OSA with no prior treatment for at least 6 months Fluent in English and able to provide informed consent.
Exclusion criteria
- No current or previous medical, neurological (e.g., traumatic brain injury, stroke) or severe psychiatric (e.g., psychosis) disorders that affect SWA enhancement and cognition, including medication affecting the central nervous system (e.g., beta blockers) - A sleep disorder other than OSA - Mild cognitive impairment (age and education adjusted cut-off on Mini Mental State Exam) or dementia diagnosis - Regular night-shift worker - Excessive daytime sleepiness (Epworth Sleepiness Scale score >16) - Professional drivers - Extreme hearing loss as the acoustic device upper limit is 76dB
Outcome results
None listed