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Can sleep and cognition in healthy adult males be improved using an acoustic device?

The efficacy of acoustic tones in slow wave sleep enhancement and cognitive function in healthy adult males

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000399392
Enrollment
27
Registered
2017-03-17
Start date
2015-10-07
Completion date
2017-04-16
Last updated
2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The deepest and most recuperative part of sleep, SWS, begins to decline from mid-adulthood. These reductions include both duration and the depth of SWS. This impairment may be linked to changes in cognitive performance. Therefore, we hypothesize that enhancing SWS via acoustic stimuli leads to improvements in cognitive performance.

Interventions

On both conditions, participants are required to come into the Monash Sleep Laboratory for two nights. During their entire eight-hour sleep period, they are required to wear the deltaboost device. This is a device which measures EEG using a standard dry electrode. It is fitted by a trained PhD student or staff member, which typically involves cleaning the electrode site as per standard laboratory PSG and putting the headband onto the participant. On the first night, the device is worn so that th

On both conditions, participants are required to come into the Monash Sleep Laboratory for two nights. During their entire eight-hour sleep period, they are required to wear the deltaboost device. This is a device which measures EEG using a standard dry electrode. It is fitted by a trained PhD student or staff member, which typically involves cleaning the electrode site as per standard laboratory PSG and putting the headband onto the participant. On the first night, the device is worn so that the participants is acclimated to the device. The headband of the device has three electrodes. These obtain an EEG signal and identify when the participant has reached N3 sleep (when the slow waves dominate). On the experimental night, tones are administered through ear phones during N3 sleep. The volume of the tones is dependent on the individual. The tone volume is set prior to the experiment, and dependent on how sensitive the individual is to noise. The tones are manually set through the DeltaBoost program and saved. The program is then used to write which file and volume the device uses. On the baseline nights, and if the participant is not flagged as sensitive, they will use a tone volume of 0.05-0.30. If the participants do flag as sensitive, the volume is reduced to 0.15. The DeltaBoost program is a custom built script that works with the DeltaBoost device. Sensitivity is determined by running the DeltaBoost data through a MATLAB script, which identifies how easily the participant is aroused by the tones. On night 1, tones are played to the participants through the headphone during the first stage of SWS. The first tone is the lowest volume setting on the device (barely audible). Arousal is monitored on the EEG, and if no EEG-determined arousal is observed, the tone is switched up one level. This continues until an arousal is observed. The preceding tone before the arousal level is then used to determine the maximum volume for the experimental night. This procedure is automated by the DeltaBoost device. The ideal tone is loud enough to invoke an EEG response (e.g., K complex) but not loud to enough to induce an arousal from sleep. The maximum tone is 72dB, which is indicated as 1 on the system. The typical tone is between 0.15 and 0.3. Tones are administered with a frequency of 1Hz during N3 only. On the control night, no tones are administered. Each participant uses the same device for each visit. They are also allocated to their own rooms. The order of the visits are randomised, with a one-week washout in between. Each visit consists of a consecutive 2 night, 2 day stay.

Sponsors

Clare Anderson
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
35 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy males Between 35 and 50 years of age Sleep efficiency of 80% or higher Habitual bedtime between 10pm and 1am, Fluent in English

Exclusion criteria

Does not have an average sleep duration between 5-6 hours or 7-9 hours Has more than 2 naps per week Scores more than 5 on the Pittsburgh Sleep Quality Index Scores more than 10 on the Epworth Sleepiness Scale: Regular shift workers and/or those who have traveled across time zones within the last 3 months History of / current psychopathology (as determined by the Structured Clinical Interview for the DSM-V) Family history of mood disorders History of / current pain disorders, neurological disorders, concussion, or cardiac disorders Has nystagmus, eye-tremor, or colour-blindness Hearing impaired Taking medication that affects the central nervous system Consumes more than 14 standard drinks per week Consumes more than 300mg of caffeine per day Smokers Presents with alpha-delta sleep patterns

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026