None listed
Conditions
Brief summary
Most athletes, at some stage in their career, will experience a problem with their sleep. Numerous situations are thought to contribute to poor sleep, including travel to competition, sleeping away from the home environment, and demanding training schedules. However, the single most common sleep complaint reported by athletes is difficulty falling asleep on the night before, and the night after, competition. Anecdotally, many athletes use sleeping tablets to overcome the difficulties of sleep on nights before/after competition. Sleeping tablets shorten how long it takes a person to fall asleep and also increases total sleeping time, but their use in athletes is problematic because of carryover effects of the drug on performance the next day. Surprisingly, very little is known about the effects of these medications on the response to exercise the following morning. This is an important issue as the use of sleeping medication in this special population may be counterproductive; that is, administration of the medication may help sleep on the nights before and after competition, but the carryover effects of the drug may significantly impair an athlete’s ability to train and/or compete the following day. This aim of this study is to examine the impact of two common sleeping medications (temazepam and zolpidem tartrate) on the physiological response to exercise in 18 male, well-trained athletes. Athletes will receive a standard dose of temazepam (10 mg as per the manufacturer's guidelines), zolpidem tartrate (10 mg as per the manufacturer's guidelines), or placebo 30 min before bedtime. Exercise performance (a time trial on a cycle ergometer) will be examined in the morning following administration of temazepam, zolpidem tartrate or placebo. Participants will complete all trails in a randomised order with a 7day washout period between each condition.
Interventions
The proposed study will employ a repeated measures design in which participants will complete a control condition and two experimental conditions in a randomised and
counterbalanced order. Participants will attend the laboratory on four occasions (1
exercise familiarisation session and three experimental sessions), each separated by 7 days. On each occasion, participants will complete one of three conditions:
• Placebo tablet
• Temazepam (10 mg) oral form, provided once, 30 minutes before bed
The proposed study will employ a repeated measures design in which participants will complete a control condition and two experimental conditions in a randomised and counterbalanced order. Participants will attend the laboratory on four occasions (1 exercise familiarisation session and three experimental sessions), each separated by 7 days. On each occasion, participants will complete one of three conditions: • Placebo tablet • Temazepam (10 mg) oral form, provided once, 30 minutes before bed • Zolpidem Tartrate (10 mg) oral form, provided once, 30 minutes before bed These are standard, recommended doses for these medications. A whole mouth check will be conducted following consumption of the placebo, Temazepam and Zolpidem Tartrate in each participant
Sponsors
Australian Catholic University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must be non-smoking males between the ages of 18-35 years, be free of any medical conditions that are likely to impact sleep, not be taking medication that is likely to disrupt sleep, and must meet the criteria of a well-trained athlete (i.e., train 3-7 times per week for at least 60 min for the last 3-5 years).
Exclusion criteria
Participants will be excluded if they have unusual sleep/wake patterns, work irregular hours, experienced a previous adverse reaction to any sleep medication, suffer from lung disease, liver damage, glaucoma, epilepsy, depression, psychosis, schizophrenia, low blood pressure, any blood disorder, or myasthenia gravis, or if they have a history of drug or alcohol dependence. Participants who currently use sleep medication will be excluded from the study.
Outcome results
None listed