Sleep in Cardiac patients with Implantable Cardioverter Defibrillators (ICD)
Sleep in Cardiac patients with Implantable Cardioverter Defibrillators (ICD)
批准号:
7529331
负责人:
Christina S McCrae
金额:
$27.61万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2008
资助国家:
美国
项目状态:
已结题
起止时间:
2008-09-17 至 2010-05-31
关键词:
AccidentsAddressAmericanAnxietyArrhythmiaBehavior TherapyBehavioralCardiacCause of DeathChronic InsomniaClinicClinicalCognitionCognitive TherapyComorbidityDevelopmentDiagnosisEffectivenessFatigueHealthHeart DiseasesImplantImplantable DefibrillatorsInterviewManualsMental DepressionMethodsObstructive Sleep ApneaOutcomePatientsPersonsPharmaceutical PreparationsPhysiciansPolysomnographyPopulationPrevalenceProcessProtocols documentationPublic HealthQuality of lifeRandomizedRandomized Clinical TrialsRateRecruitment ActivityResearchResearch PersonnelRiskScreening procedureShockSleepSleep Apnea SyndromesSleep DisordersSleep disturbancesSleeplessnessStagingTelephoneTestingUniversitiesVulnerable PopulationsWeightbasechronic paindesigndiariesearly /brief intervention /therapyexperiencefollow-upimplantationimprovedmortalitynovelpsychologicpsychological outcomes
中文摘要
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英文摘要
DESCRIPTION (provided by investigator): Cardiac disease is the leading cause of death in the U.S. Because the Implantable Cardioverter Defibrillator (ICD) significantly reduces cardiac mortality, approximately 200,000 ICDs are implanted each year. Sleep disturbance represents a significant comorbidity for ~57 percent of ICD patients, potentially contributing to a variety of negative consequences (decreased quality of life, accidents) in this already vulnerable patient population. Unfortunately, information regarding the specific types of sleep disturbance experienced is not available. Such information is important, because different sleep disorders require very different treatment approaches. Specific Aim 1 addresses this issue by using a [3 stage] process to differentially diagnose sleep disorders in ICD patients: 1-clinical interview; 2-polysomnography; 3-sleep diaries. Obstructive sleep apnea (OSA) and insomnia are likely to be the two most common sleep disorders in ICD patients. Effective treatment exists for OSA. However, the best treatment approach for insomnia in these patients is unclear. Sleep medications provide effective short-term relief, but may not the best approach for chronic insomnia in ICD patients. Cognitive behavioral therapy for insomnia (CBTi) represents an attractive treatment alternative, because it is effective, carries little risk of unwanted effects, and is preferred to sleep medication by the majority of patients. Unfortunately, no definitive conclusions can be drawn about CBTi's effectiveness in ICD patients, because these patients are typically excluded from behavioral intervention protocols. Specific Aims 2 and 3 involve a randomized clinical trial (RCT) to evaluate the effects on sleep (Aim 2) and other daytime outcomes (Aim 3) of a brief cognitive-behavioral intervention against a waitlist control in ICD patients with insomnia. A brief, multiple-component CBTi protocol will be developed that includes established behavioral approaches to treating insomnia plus several novel components to target the negative cognitions and anxieties associated with cardiac disease and ICD implantation. ICD patients with insomnia will be randomly assigned to either treatment or a waitlist control. Treatment will be individually administered during 2 `in-person' sessions & 2 `telephone' sessions. Sleep and other outcomes (psychological functioning, daytime functioning, [quality of life, cardiac functioning (arrhythmic burden)], and ICD adjustment will be evaluated at baseline, post treatment, & 3 month follow-up. Sleep disturbance in the context of cardiac disease and ICD implantation represents a major health threat for many Americans. This research addresses the public health need for information on the types of sleep disorders experienced by ICD patients and for the development of behavioral interventions that target insomnia in this vulnerable population. The information to be gained has broad implications not only for other patient populations likely to suffer from insomnia (i.e., chronic pain), but also for those suffering from other behavioral/heath concerns (i.e., weight management, depression).
PUBLIC HEALTH RELEVANCE: Sleep disturbance in the context of cardiac disease and ICD implantation represents a major health threat for many Americans. This research addresses the public health need for information on the types of sleep disorders experienced by ICD patients and for the development of behavioral interventions that target insomnia in this vulnerable population. The information to be gained has broad implications not only for other patient populations likely to suffer from insomnia (i.e., chronic pain), but also for those suffering from other behavioral/heath concerns (i.e., weight management, depression).
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依托单位:
海外基金