Sleep and speech: Objectively monitoring the residual effects of sleep-promoting compounds

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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000033448

Acronym

none

Enrollment

Registered

2016-01-18

Start date

2014-07-18

Completion date

2016-01-11

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

To investigate the residual effects of temazepam and zolpidem, and to investigate the analysis of speech for objectively measuring these changes.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 25 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy adults

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.

Outcome results