None listed
Conditions
Brief summary
The efficacy of Temazepam on sleep disordered breathing in untreated patients with mild to moderate OSA as measured by the Apnea Hypopnea Index (AHI) via standard overnight polysomnography (PSG). The effect of temazepam on OSA will be correlated with awake HVR and HCVR. The hypothesis is that Temazepam reduction of OSA will be correlated with the baseline HVR and HCVR.
Interventions
10 mg Temazepam over 1 night only administered orally. As this is a crossover study, there will be a 2 week washout period.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients must be male, aged 18 to 70, Body Mass Index (BMI) < 35, diagnosed obstructive sleep apnea by overnight polysomnography (Apnea-Hypopnea Index =5, = 30), and refuse or cannot tolerate a continuous positive airway pressure device and/or a mandibular advancement splint.
Exclusion criteria
Patients will be excluded if they are suffering from any uncontrolled concurrent medical or psychiatric illness, if they are currently taking any medications that are known to affect sleep or that may cause a drug interaction with Temazepam, if they have medical conditions that would contraindicate administration of Temazepam or if they have irregular sleep patterns, such as shift-workers.
Outcome results
None listed