N/A N=189 Randomized Treatment

Insomnia Self-Management in Heart Failure

Cardiac Failure · Heart Failure · Congestive Heart Failure · Heart Failure, Congestive · Sleep Initiation and Maintenance Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02660385 ↗

Enrolled (actual)

189

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Change in Insomnia Severity — -6.60; -3.46 score on a scale — p=0.0002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioral Therapy for Insomnia (Behavioral); Self-Management Education for Heart Failure (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Yale University
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Insomnia Severity	-6.60; -3.46	0.0002 sig
PRIMARY Change in Fatigue	-3.24; -1.13	0.0723
PRIMARY Change in Sleep Efficiency-measured With PSQI	4.87; -1.96	0.0110 sig
PRIMARY Change in Sleep Quality	-2.78; -0.51	<0.0001 sig
PRIMARY Change in Sleep Efficiency-measured With Actigraphy	-0.5; 0.3	0.4356
PRIMARY Change From Baseline in Fatigue	-3.16; -1.37; -4.26; -1.49	0.0148 sig
PRIMARY Change From Baseline in Insomnia Severity	-6.63; -4.06; -6.69; -4.57	0.0130 sig
PRIMARY Change From Baseline in Sleep Quality	-3.02; -0.92; -2.89; -1.36	0.0130 sig
PRIMARY Change From Baseline in Sleep Efficiency Measured With PSQI (%)	5.21; 0.91; 4.91; 1.17	0.0130 sig
PRIMARY Change From Baseline in Sleep Efficiency Measured With Actigraphy	-0.53; 0.17; -0.44; 0.01	0.6358
SECONDARY Change in Sleep Duration	0.24; -0.44	0.0318 sig
SECONDARY Change From Baseline in Sleep Duration	0.21; -0.18; 0.03; -0.18	0.2722
SECONDARY Change in Anxiety Symptoms	-2.08; -0.32	0.0954
SECONDARY Change From Baseline in Anxiety Symptoms	-2.73; -1.67; -2.85; -1.90	0.4222
SECONDARY Change in Depressive Symptoms	-1.93; -2.50	0.5781
SECONDARY Change From Baseline in Depressive Symptoms	-1.55; -2.549; -1.11; -2.71	0.1238
SECONDARY Change in Sleepiness	-1.39; -0.23	0.0558
SECONDARY Change From Baseline in Sleepiness	-1.99; -0.68; -2.15; -0.84	0.0230 sig
SECONDARY Change in Dyspnea	-0.77; 0.34	0.4597
SECONDARY Change From Baseline in Dyspnea	-0.12; 1.20; -1.32; 0.41	0.1943
SECONDARY Change in Psychomotor Vigilance	-0.10; -0.30	0.0027 sig
SECONDARY Change From Baseline in Psychomotor Vigilance	-0.16; -0.55; -0.25; -0.48	0.0792
SECONDARY Change in Functional Performance	-0.79; 1.17	0.0656
SECONDARY Change From Baseline in Functional Performance	-0.61; 1.40; 0.06; 2.56	0.2174
SECONDARY Change in Distance (Feet) Traveled During Six Minute Walk Test	101.0; 44.0; 117.4; 61.3	0.0509
SECONDARY Change in Distance (Feet) Traveled During Six Minute Walk Test	101.0; 44.0; 117.4; 61.3	0.0509
SECONDARY Cost Effectiveness	32; 42; 891; 1014; 257; 235.69	0.955
SECONDARY Change From Baseline in Sleep Latency (Minutes)	-14.06; -0.17; -10.86; -1.83	0.0130 sig
SECONDARY Change in Sleep Latency	-4.39; -2.11	0.7496
SECONDARY Change in Sleep Related Impairment	-8.56; -7.54	0.3821
SECONDARY Change From Baseline in Sleep Related Impairment	-10.23; -9.54; -10.74; -10.23	0.7204

Summary

Chronic insomnia may contribute to the development and exacerbation of heart failure (HF), incident mortality and contributes to common and disabling symptoms (fatigue, dyspnea, anxiety, depression, excessive daytime sleepiness, and pain) and decrements in objective and subjective functional performance. The purposes of the study are to evaluate the sustained effects of CBT-I on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia. The effects of the treatment on outcomes of HF (hospitalization, death) and costs of the treatment will also be examined. A total of 200 participants will be randomized to 4 bi-weekly group sessions of cognitive behavioral therapy for CBT-I (behavioral was to improve insomnia and sleep) or HF self-management education. Participants will complete wrist actigraph (wrist-watch like accelerometer) measures of sleep, diaries, reaction time, and 6 minute walk test distance. They will also complete self-report measures of insomnia, sleep, symptoms, and functional performance. In addition the effects on symptoms and function over a period of one year.

Eligibility Criteria

Inclusion Criteria

stable chronic heart failure, chronic insomnia, English speaking/reading,

Exclusion Criteria

untreated sleep disordered breathing or restless legs syndrome, rotating/night shift work, active illicit drug use, bipolar disorder, neuromuscular conditions affecting the non-dominant arm end-stage renal failure, significant cognitive impairment, unstable medical or psychiatric disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02660385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.