Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Typ… (NCT03818581) | Clinical Trial Compass
CompletedPhase 4
Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes
United States108 participantsStarted 2019-03-15
Plain-language summary
The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized placebo-controlled trial for 3 months.
Who can participate
Age range25 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men or women of any ethnic origin
✓. Written informed consent is obtained
✓. Speaks and writes in English
✓. A willingness and ability to comply with study procedures.
✓. Age 25-75 years
✓. Diagnosis of Type 2 diabetes with suboptimally controlled blood sugar determined by HbA1c \> 6.5% (and \< 10.0%) at both the screening and randomization visits
✓. No changes in diabetes medication in the previous month
✓. DSM-5 criteria for Insomnia Disorder
Exclusion criteria
✕. Sleep and medical factors:
✕. Diagnosis of severe obstructive sleep apnea not using CPAP (can be included if CPAP adherent), or other untreated primary sleep disorders (e.g. narcolepsy, moderate to severe restless legs syndrome)
✕. Shift workers
✕. Use of hypnotic medications more than twice per week in the past month
✕. Unwillingness to not use sedative-hypnotics (other than suvorexant) during the study period
✕. Unwillingness to maintain stable diabetes medication during the study unless medically indicated