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Trial registered on ANZCTR


Registration number
ACTRN12617000399392
Ethics application status
Approved
Date submitted
5/10/2016
Date registered
17/03/2017
Date last updated
14/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can sleep and cognition in healthy adult males be improved using an acoustic device?
Scientific title
The efficacy of acoustic tones in slow wave sleep enhancement and cognitive function in healthy adult males
Secondary ID [1] 290210 0
Nil known
Universal Trial Number (UTN)
U1111-1188-0751
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleeping difficulties 300377 0
Impaired cognition 300378 0
Impaired slow wave sleep (SWS) 300379 0
Condition category
Condition code
Neurological 300242 300242 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295974 0
Treatment: Devices
Comparator / control treatment
During the control night, no tones are administered.
Control group
Placebo

Outcomes
Primary outcome [1] 299719 0
The amount of delta waves throughout sleep, particularly during slow wave sleep.

The data is scored via polysomnography using the AASM scoring manual to determine the amount of slow wave sleep the participant has had during the night.
Timepoint [1] 299719 0
The entire eight-hour sleep period for the control and therapy nights are analysed.
Primary outcome [2] 300148 0
Amplitude of delta waves throughout sleep, particularly during slow wave sleep.

It is analysed via power spectral analyses (an automated Matlab script) to determine the amplitude of the delta waves.
Timepoint [2] 300148 0
The entire eight-hour sleep period for the control and therapy nights are analysed.
Secondary outcome [1] 327944 0
Cognitive functioning. Both executive and hippocampal functioning are measured using a variety of cognitive tests: paired associates task, psychomotor vigilance task (PVT), Karolinska drowsiness test (KDT), karolinska sleepiness scale (KSS), go nogo, groton maze task, n-back, tower of london, transverse patterning, verbal fluency and visual working memory task. There are alternate forms for all of the cognitive tasks.
Timepoint [1] 327944 0
The tests for alertness occur hourly, starting 1.5 hours after the participant's wake time, alternating between a single KSS (approx. 1 minute) and the full attention and vigilance test battery (10 minute PVT, 3 minute eyes open KDT, 2 minute eyes closed KDT & KSS).
.i.e. hour 1 is a single KSS, hour 2 is a attention and vigilance battery, hour 3 is a single KSS up until 9.5 hours after wake, when the study finishes.

The other cognitive tasks are split into two neurocognitive test batteries, administered 2 and 4 hours after wake time.
First test battery: visual working memory - capacity and filtering, approx. 10 minutes each, verbal fluency, approx 10 minutes, tower of london, approx 10 minutes.
Second test battery: go/nogo - approx 10 minutes, n-back, approx 10 minutes.

Eligibility
Key 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
Minimum age
35 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/10/2015
Date of last participant enrolment
Anticipated
Actual
16/04/2017
Date of last data collection
Anticipated
Actual
30/04/2017
Sample size
Target
24
Accrual to date
Final
27
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294573 0
Government body
Name [1] 294573 0
Cooperative Research Centre (CRC) for Alertness, Safety and Productivity
Country [1] 294573 0
Australia
Funding source category [2] 294659 0
Commercial sector/Industry
Name [2] 294659 0
Philips
Country [2] 294659 0
United States of America
Primary sponsor type
Individual
Name
Clare Anderson
Address
18 Innovation Walk (Building 17), Room 534
Monash University, Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 293515 0
Individual
Name [1] 293515 0
Sean Drummond
Address [1] 293515 0
18 Innovation Walk (Building 17)
Monash University, Clayton, VIC 3800
Country [1] 293515 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296006 0
Monash University Human Ethics Committee (MUHREC)
Ethics committee address [1] 296006 0
Ethics committee country [1] 296006 0
Australia
Date submitted for ethics approval [1] 296006 0
Approval date [1] 296006 0
27/04/2015
Ethics approval number [1] 296006 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69250 0
A/Prof Clare Anderson
Address 69250 0
18 Innovation Walk (Building 17), Room 534
Monash University Clayton VIC 3800
Country 69250 0
Australia
Phone 69250 0
+61 3 9905 1714
Fax 69250 0
Email 69250 0
clare.anderson@monash.edu
Contact person for public queries
Name 69251 0
Clare Anderson
Address 69251 0
18 Innovation Walk (Building 17), Room 534
Monash University Clayton VIC 3800
Country 69251 0
Australia
Phone 69251 0
+61 3 9905 1714
Fax 69251 0
Email 69251 0
clare.anderson@monash.edu
Contact person for scientific queries
Name 69252 0
Clare Anderson
Address 69252 0
18 Innovation Walk (Building 17), Room 534
Monash University Clayton VIC 3800
Country 69252 0
Australia
Phone 69252 0
+61 3 9905 1714
Fax 69252 0
Email 69252 0
clare.anderson@monash.edu

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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