Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000033448
Ethics application status
Approved
Date submitted
20/05/2014
Date registered
18/01/2016
Date last updated
18/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sleep and speech: Objectively monitoring the residual effects of sleep-promoting compounds
Scientific title
Do healthy adults aged 18 - 25 given zolpidem 10mg or temazepam 10mg before bed compared to no treatment show any effect to alertness and executive function, as indicated by speech, upon waking in the middle of the night or waking in the morning.
Secondary ID [1] 284627 0
Nil known
Universal Trial Number (UTN)
none
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive detriment due to residual effects to the central nervous system after using zolpidem or temazepam. 291907 0
Condition category
Condition code
Injuries and Accidents 292252 292252 0 0
Other injuries and accidents
Mental Health 292486 292486 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over the course of the protocol participants will take a single dose of each drug:

A 10mg single dose of zolpidem administered orally via a capsule before bed;

A 10mg single dose of temazepam administered orally via a capsule before bed.

There are four groups: Placebo, temazepam and zolpidem are woken during the first slow wave sleep episode after sleep onset. Another placebo group is woken during the first rapid eye movement episode.

The wash out period between treatments is 7 days.
Intervention code [1] 289377 0
Treatment: Drugs
Comparator / control treatment
There are two placebo treatments:

Placebo group 1 is woken during the first slow wave sleep episode after sleep onset.

Placebo group 2 is woken during the first rapid eye movement episode after sleep onset.

The placebo capsule contains microcellulose.

Each placebo capsule is identical to the zolpidem and temazepam capsules.
Control group
Placebo

Outcomes
Primary outcome [1] 292160 0
The primary outcome is a composite of speech characteristics. These are the following speech characteristics:

pause length;
speech rate;
changes to fundamental frequency;
variability to fundamental frequency;
change in pitch;
pitch variability;
intensity.
These outcomes are assessed by computer analysing speech samples elicited by reading passages, sustaining vowel sounds, and free talking.
Timepoint [1] 292160 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Primary outcome [2] 292161 0
The primary outcome is a composite of speech characteristics. These are the following speech characteristics:

pause length;
speech rate;
changes to fundamental frequency;
variability to fundamental frequency;
change in pitch;
pitch variability;
intensity.
These outcomes are assessed by computer analysing speech samples elicited by reading passages, sustaining vowel sounds, and free talking.
Timepoint [2] 292161 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Primary outcome [3] 296477 0
The primary outcome is a composite of speech characteristics. These are the following speech characteristics:

pause length;
speech rate;
changes to fundamental frequency;
variability to fundamental frequency;
change in pitch;
pitch variability;
intensity.
These outcomes are assessed by computer analysing speech samples elicited by reading passages, sustaining vowel sounds, and free talking.
Timepoint [3] 296477 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [1] 308331 0
Performance on the Karolinska Sleepiness Scale (participants indicate how they would rate their sleepiness in the last 10 minutes on a 9-point Likert scale).
Timepoint [1] 308331 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [2] 318536 0
Performance on the Karolinska Sleepiness Scale (participants indicate how they would rate their sleepiness in the last 10 minutes on a 9-point Likert scale).
Timepoint [2] 318536 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [3] 318537 0
Performance on the Karolinska Sleepiness Scale (participants indicate how they would rate their sleepiness in the last 10 minutes on a 9-point Likert scale).
Timepoint [3] 318537 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [4] 319302 0
Performance on the Psychomotor Vigilance Task (participants respond to stimuli on an otherwise blank screen as quickly as possible).
Timepoint [4] 319302 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [5] 319303 0
Performance on the Psychomotor Vigilance Task (participants respond to stimuli on an otherwise blank screen as quickly as possible).
Timepoint [5] 319303 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [6] 319304 0
Performance on the Psychomotor Vigilance Task (participants respond to stimuli on an otherwise blank screen as quickly as possible).
Timepoint [6] 319304 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [7] 319305 0
EEG (brain activity) during the Karolinska Drowsiness Test (participants stare at a white dot in the middle of a black computer screen for up to four minutes while minimising blinking and body movement).
Timepoint [7] 319305 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [8] 319306 0
EEG (brain activity) during the Karolinska Drowsiness Test (participants stare at a white dot in the middle of a black computer screen for up to four minutes while minimising blinking and body movement).
Timepoint [8] 319306 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [9] 319307 0
EEG (brain activity) during the Karolinska Drowsiness Test (participants stare at a white dot in the middle of a black computer screen for up to four minutes while minimising blinking and body movement).
Timepoint [9] 319307 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [10] 319308 0
Performance on the Cogstate test battery. The Cogstate test battery consists of four different tasks involving a card that is presented on a computer screen. Participants are required to perform a specific action, after which (regardless of whether it is correct or incorrect action), they must repeat the same process with a proceeding card.
Timepoint [10] 319308 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [11] 319309 0
Performance on the Cogstate test battery. The Cogstate test battery consists of four different tasks involving a card that is presented on a computer screen. Participants are required to perform a specific action, after which (regardless of whether it is correct or incorrect action), they must repeat the same process with a proceeding card.
Timepoint [11] 319309 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [12] 319310 0
Performance on the Cogstate test battery. The Cogstate test battery consists of four different tasks involving a card that is presented on a computer screen. Participants are required to perform a specific action, after which (regardless of whether it is correct or incorrect action), they must repeat the same process with a proceeding card.
Timepoint [12] 319310 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [13] 319311 0
Word learning task, where participants learn a set of aurally-presented nonwords and their associated images. Performance on this task is not directly measured, but the task contents are recalled and recognised in the subsequent two timepoints.
Timepoint [13] 319311 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [14] 319312 0
Performance on the word recall task (participants recall the nonwords associated with presented images that were learned during the first timepoint).
Timepoint [14] 319312 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [15] 319313 0
Performance on the word recall task (participants recall the nonwords associated with presented images that were learned during the first timepoint).
Timepoint [15] 319313 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [16] 319314 0
Performance on the word recognition task (participants choose which presented image (out of three) is associated with the aurally-presented nonwords that were learned during the first timepoint).
Timepoint [16] 319314 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [17] 319315 0
Performance on the word recognition task (participants choose which presented image (out of three) is associated with the aurally-presented nonwords that were learned during the first timepoint).
Timepoint [17] 319315 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [18] 319316 0
Performance on the word recognition task (participants choose which presented image (out of three) is associated with the aurally-presented nonwords that were learned during the first timepoint).
Timepoint [18] 319316 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [19] 319317 0
Performance on the lexical decision-making task (participants are required to listen to a mixture of words and nonwords, and to determine if each presented word is a word or a nonword).
Timepoint [19] 319317 0
Approximately three hours before habitual bedtime. Habitual bedtime is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).
Secondary outcome [20] 319318 0
Performance on the lexical decision-making task (participants are required to listen to a mixture of words and nonwords, and to determine if each presented word is a word or a nonword).
Timepoint [20] 319318 0
After the participant is awakened during the first slow wave sleep episode after sleep onset (post drug administration). This is determined using EEG and the American Academy of Sleep Medicine's sleep scoring criteria.
Secondary outcome [21] 319319 0
Performance on the lexical decision-making task (participants are required to listen to a mixture of words and nonwords, and to determine if each presented word is a word or a nonword).
Timepoint [21] 319319 0
At participants' habitual wake time. Habitual wake time is determined using a combination of participant sleep diary and data from an actigraph (a sleep/wake-measuring device).

Eligibility
Key inclusion criteria
Healthy adults
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not having, average, between 7 and 9 hours of sleep.
Taking more than 2 naps a week.
Currently taking medication affecting the central nervous system.
Are recreational drug or alcohol abusers
Have 4 or more standard alcoholic drinks in one sitting or more than 2 standard alcoholic drinks per week.
Currently smoke.
Have a history of neurological trauma
Present with poor vocal health
Present with a medical condition contraindicative for temazepam and zolpidem
Have worked shift work 3 months before the study
Have crossed more than two time zones in the last month
Use more than 300mg of caffeine a day
Suffer from sleep disturbances, disorders
Suffer from daytime sleepiness
Have used temazepam or zolpidem before.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomisation process has been used to order the four conditions for each participant. A crossover design ensures every participant is exposed to all four conditions: temazepam, zolpidem and two placebo conditions. Allocation concealment is in place as all drugs for all four conditions are received in numbered vials. The allocation of the drugs to vial number is only known by the dispensing pharmacist. The allocation of the drugs to vial number was noted on a slip of paper and placed in a sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The software Randlist was used to generate a list which randomises the sequence the four conditions are presented to each participant.
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
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/07/2014
Date of last participant enrolment
Anticipated
20/08/2015
Actual
11/01/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 289233 0
Government body
Name [1] 289233 0
Australian Research Council linkage grant
Country [1] 289233 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Clayton campus
Wellington Road
Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 287907 0
Individual
Name [1] 287907 0
Dr Adam Vogel
Address [1] 287907 0
Melbourne University
550 Swanston Street
Parkville/Melbourne
VIC 3010
Country [1] 287907 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291003 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 291003 0
Ethics committee country [1] 291003 0
Australia
Date submitted for ethics approval [1] 291003 0
Approval date [1] 291003 0
06/05/2013
Ethics approval number [1] 291003 0
CF13/465 - 2013000196

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

Contacts
Principal investigator
Name 48366 0
Dr Adam Vogel
Address 48366 0
Melbourne University
550 Swanston Street
Parkville/Melbourne
VIC 3010
Country 48366 0
Australia
Phone 48366 0
+61 (0) 390355334
Fax 48366 0
Email 48366 0
[email protected]
Contact person for public queries
Name 48367 0
Adam Vogel
Address 48367 0
Melbourne University
550 Swanston Street
Parkville/Melbourne
VIC 3010
Country 48367 0
Australia
Phone 48367 0
+61 (0) 390355334
Fax 48367 0
Email 48367 0
[email protected]
Contact person for scientific queries
Name 48368 0
Adam Vogel
Address 48368 0
Melbourne University
550 Swanston Street
Parkville/Melbourne
VIC 3010
Country 48368 0
Australia
Phone 48368 0
+61 (0) 390355334
Fax 48368 0
Email 48368 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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