He said the study was conducted at 26 dialysis centers in Albuquerque and Seattle starting in 2018. “We tested 933 patients and found that just under 50% of them had moderately severe insomnia. Of these, just over a quarter agreed to participate in the trial. Very interested It was expensive.”
Ultimately, 126 participants were divided into three groups. One group was treated with CBT-I, a standardized intervention delivered via Zoom by a master’s degree-trained therapist. CBT-I helps people reframe inaccurate or unhelpful beliefs about sleep and provides behavioral training to promote relaxation and healthy sleep habits.
The second group received trazodone, an older antidepressant that is widely prescribed off-label for insomnia because of its sedative effects. A third group was randomly selected and received an inactive tablet as a placebo instead of trazodone. Each group received six weeks of treatment, and their insomnia symptoms were assessed after seven weeks and again after 25 weeks.
Sleep quality was assessed using wrist-worn devices that recorded how much patients turned and turned during the night, or by questionnaires in which patients reported symptoms such as sleepiness and anxiety.
“Interestingly, when all interventions, including placebo, were superimposed, there was no clear effect for either the CBT-I intervention or the trazodone intervention,” Unruh said.
“The study results were a little disappointing, but that’s how it works,” he said. “Most studies are not positive. Most studies are negative, so we need to design studies so that they are still informative. I think this one is.”
Although it was not intended for this purpose, the study detected an increased risk of serious cardiac complications in patients prescribed trazodone, Unruh said. “This is actually plausible given observations in other studies.”
However, he said there are various possible explanations for the failure of either intervention to improve sleep in dialysis patients. One is that the dialysis itself may be causing the symptoms in some way. Another thing he points out is that dialysis patients tend to have multiple serious medical conditions.
“These are people who have multiple reasons for disrupting their sleep,” Unruh says. “So we’re treating insomnia, but we also have sleep apnea, restless legs, circadian rhythm disorders? Perhaps, as a practice, the criteria for referral to a doctor for sleeping pills is… You’ll probably need to set it lower.”
A related possibility is that insomnia may be caused by side effects or interactions of the multiple medications that many dialysis patients take for their illnesses, he said.
“The average dialysis patient takes 13 different medications and takes at least 19 pills a day,” Unruh says. “They have comorbidities and medications that come with end-stage renal disease.”
Kidney transplantation is the only treatment for patients with end-stage renal disease, but Unruh and his colleagues share a common interest in improving patients’ quality of life. They previously partnered on research into treating depression in dialysis patients, which has been adopted by a major dialysis center network.
“That’s why we went into this field,” he said. “When we do these large studies and surveys, we find that a large proportion of people on dialysis have sleep disorders and sleep disturbances that are largely unaddressed.”
