Sleep-HD (CBT-I)
Trial question
What is the role of CBT-I in patients undergoing hemodialysis with mild or moderate chronic insomnia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 84
84 patients (41 female, 43 male)
Inclusion criteria: patients undergoing hemodialysis with Insomnia Severity Index score ≥ 10, with sleep disturbances on ≥ 3 nights/week for ≥ 3 months
Key exclusion criteria: severe cognitive impairment; severe depressive symptoms; suicidal ideation; alcohol or substance misuse; severe restless legs syndrome; pregnancy/lactation; anticipated life expectancy < 3 months
Interventions
N=43 CBT-I (six 30-minute telehealth CBT-I sessions weekly for 6 weeks)
N=41 placebo (matching placebo for 6 weeks)
Primary outcome
Reduction in Insomnia Severity Index score at week 7
3.7
3.1
3.7 points
2.8 points
1.9 points
0.9 points
0.0 points
CBT-I
Placebo
No significant
difference ↔
No significant difference in reduction in Insomnia Severity Index score at week 7 (3.7 points vs. 3.1 points; AD 0.58 points, 95% CI -1.86 to 3.03)
Secondary outcomes
No significant difference in reduction in Insomnia Severity Index score at week 25 (4.8 points vs. 4.3 points; AD 0.51 points, 95% CI -2.37 to 3.39)
Significant increase in reduction in Pittsburgh Sleep Quality Index at week 7 (2.6 vs. -0.4 ; AD 2.95 , 95% CI 1.49 to 4.42)
No significant difference in reduction in Epworth Sleepiness Scale at week 7 (1.1 points vs. 1.3 points; AD -0.17 points, 95% CI -1.91 to 1.56)
Safety outcomes
No significant difference in non-serious adverse events.
Conclusion
In patients undergoing hemodialysis with Insomnia Severity Index score ≥ 10, with sleep disturbances on ≥ 3 nights/week for ≥ 3 months, CBT-I was not superior to placebo with respect to reduction in Insomnia Severity Index score at week 7.
Reference
Rajnish Mehrotra, Daniel Cukor, Susan M McCurry et al. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188.
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