About SONO Sleep Study
SONO will help to change the subtyping of insomnia, its clinical management, and future research
Insomnia is a common problem with important health consequences
Insomnia can lead to cardiovascular and metabolic problems. For example, adults with insomnia have a 3- to 5-fold increased chance of developing hypertension or diabetes than those without insomnia.
Effective insomnia treatments are available
Cognitive-Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment. The majority of people who undergo CBT-I experience a significant symptom reduction, with about 40-50% experiencing full remission of their insomnia. Thus, despite being a highly effective treatment, some patients need addition treatment, such as medication, after CBT-I. Low-dose trazodone, the second-most prescribed medication for insomnia in the U.S., has been shown to be effective and have a relatively low risk profile in several patient populations, but has not been tested in a Randomized Clinical Trial (RCT) among those who do not experience remission after CBT-I .
Insomnia with short sleep duration (ISS) is a subtype with increased health risks, compared to insomnia with normal sleep duration (INS).
Although we know a great deal about insomnia and its treatment, important questions remain: Does insomnia subtype (ISS versus INS) predict response to CBT-I? Does trazodone effectively treat insomnia among non-responders to CBT-I? And, do CBT-I or trazodone impact biological indicators of stress?
To address these questions, we will first conduct an open cohort study of CBT-I for adults with insomnia and compare the outcomes of study participants with ISS to those with INS. Among participants who do not remit with CBT-I, we will conduct a double-blind RCT comparing trazodone vs. placebo. Participants will include 600 adults (n≈150 per clinical site) 18 years or older with a diagnosis of insomnia and elevated blood pressure levels and no other significant medical or psychiatric problems.
The overall goal is to determine the effect of insomnia subtype on insomnia remission and secondary outcomes (e.g., symptom severity, sleep efficiency) after treatment with CBT-I and to test the efficacy of trazodone among non-remitters to CBT-I in a placebo-controlled RCT.
Our study is will help to change the subtyping of insomnia, its clinical management, and future research.