- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00346554
To Study the Prevalence of Insomnia in Geriatric COPD Patients Who Are Enrolled in a Pulmonary Rehabilitation Program.
Visão geral do estudo
Status
Condições
Descrição detalhada
Hackensack University Medical Center Institutional Review Board
PROTOCOL: To study the prevalence of insomnia in geriatric COPD patients who are enrolled in a pulmonary rehabilitation program.
I. OBJECTIVES OF THE STUDY
RATIONALE:
The goal for geriatric patients with COPD and enrolled in pulmonary rehabilitation programs is to improve the quality of life. COPD is known to be worse at night as are other respiratory problems such as CHF. Saturation is known to get worse nocturnally as well. Furthermore, these COPD rehabilitation patients tend to be older, and increasing age is associated with an increase in the incidence of sleep disorders. We suspect that there is an increase in the incidence of difficulty initiating and maintaining sleep in COPD patients. A preliminary study was done by the chest medicine specialist in our group, but the results were not comparable to national statistics and were inconclusive. We plan to further evaluate the geriatric COPD patients in pulmonary rehabilitation with initial screening questionnaire and diagnostic screening questionnaires (MMSE, Beck's Anxiety Inventory, Beck's Depression Inventory, and Epworth Sleepiness Scale).
GOALS:
- To determine the incidence and prevalence of insomnia (difficulty initiating sleep (DIS), and/or difficulty maintaining sleep (DMS) in the geriatric population with COPD in a rehabilitation program.
- To determine how many of these patients suffer from anxiety and/or depression.
HYPOTHESIS:
The incidence of insomnia (DIS and/or DMS), along with anxiety/depression is more prevalent in geriatric patients with COPD.
II. BACKGROUND MATERIAL According to the American Academy of Sleep Medicine (AASM), over a six-month period, 20 million Americans complained of insomnia.
COPD patients tend to have decreased total sleep time (32% reported total sleep time less than 6 hours). According to previous studies conducted, the following was reported:
- 15% reported to have insomnia;
- 28% reported poor quality sleep due to anxiety and/or depression;
- 12% reported > 3 awakenings due to unknown origin.
RESULTS OF PILOT:
In the pilot study, a preliminary general (initial) questionnaire was used and will continue to be used as a tool for general screening purposes. And diagnostic questionnaires will be used, which are the following:
- Beck's Anxiety Inventory
- Beck's Depression Inventory
- Epworth Sleepiness Scale
- MMSE
III. DRUG INFORMATION
No drugs are used in this study protocol.
IV. INCLUSIONARY CRITERIA
Geriatric patients with COPD enrolled in the rehabilitation program with FEV1<60%.
V. EXCLUSIONARY CRITERIA
Geriatric patients without a clear diagnosis of COPD. Geriatric patients whose FEV1>60%. Geriatric patients who are unable to answer the questionnaire.
VI. RECRUITMENT PROCEDURES
Geriatric patients in the HUMC pulmonary rehabilitation program who consent to answer the questionnaire and with an FEV1<60% will be enrolled.
VII. METHODOLOGY
Screening: Charts will be reviewed to see which patients meet the criteria of the study.
Informed Consent: If the patient is eligible for diagnostic screening, then an informed consent will be taken.
Randomization: None
Baseline evaluation: Geriatric patients will be asked the questions in the questionnaire.
Follow-up: If insomnia is found, patient will be referred for further treatment.
Withdrawal and Termination: The patient is unable to complete the questionnaire.
VIII. DISCOMFORT AND RISKS
No direct risks to the patient. Failure to follow-up in the clinic if indicated could be problematic.
IX. BENEFITS
Recognition and treatment of sleep problems in this group of patients will add to our understanding of problems in COPD.
X. CRITERIA FOR EVALUATING RESPONSE
No response anticipated from the study protocol.
XI. CONFIDENTIALITY
All results will be kept confidential. Data will only be used by the investigators. Data can be reviewed by the IRB at any time. HIPPA forms will be used for the patient's permission.
XII. PRIMARY INVESTIGATOR
Hormoz Ashtyani, M.D.
CO PRIMARY INVESTIGATOR
Susan Zafarlotfi Ph.D
GERIATRIC MEDICINE SPECIALIST
Knight R. Steel, M.D.
RESEARCH COORDINATOR
Mohammad Quadri, M.D. (MBA) RPSGT
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center - Pulmonary Rehabilitation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- COPD
- rehabilitation program
- FEV1<60%
Exclusion Criteria:
- FEV1>60%
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hormoz Ashtyani, MD, Hackensack Meridian Health
- Investigador principal: Susan Zafarlotfi, Ph.D, Hackensack Meridian Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 06.01.008
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