Investigate the feasibility of an RCT of non-pharmacological interventions on sleep and quality of life of patients with HF and additionally test the effect of sleep hygiene therapy, phototherapy and combination therapy (phototherapy +sleep hygiene) sleep compared with guidance on disease management.
Methods: This was a pilot of a blinded randomized clinical trial in which 32 subjects (women: 59.4%; mean age: 55.4 (SD=10.4) years, NYHA II-III: 90.7%) were randomized to three intervention groups (phototherapy, measures of sleep hygiene and combined therapy) and a control group (guidance on management of the disease and medications) to test the effectiveness of sleep interventions in sleep (Pittsburg Sleep Quality Index) and health-related quality of life (Minnesota Living with Heart Failure Questionnaire) improvement. Participants were assessed at baseline, 4th, 8th, 12th and 24th weeks of follow up. Outcomes were analyzed longitudinally by repeated measures-ANOVA. An intention-to-treat analysis was conducted.
Results: Statistically significant improvement were found in both intervention and control groups in sleep pattern by the 12th week (F: 63.09, p<0,001) and 24th week (F:64.06, p<0,001), and in related-health quality of life by the 12th week (F: 13.81, p<0,001) and 24th week (F:15.02, p<0,001). No statistically significant difference was found in sleep and health-related quality of life improvement between groups.
Conclusion:
Measures of sleep hygiene and phototherapy, isolated or combined with each other, and education about the management of the symptoms of the disease have a similar positive effect on sleep and quality of life of patients with HF. Studies with larger samples are needed.
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