Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training (CIPOD)
A research study to assess the baseline olfactory function, mental health status, clinical severity, and immunological profile in patients with smell loss. The impact of a 3-month olfactory training program on smell function, immunological changes, and mental health in patients with smell loss will be evaluated.
The primary purpose of this study is to investigate tissue and blood samples to identify molecules that may be related to smell loss, ultimately aiming to develop future treatments for this condition and correlate with cognition.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Adult patients with chronic rhinosinusitis (CRS) with nasal polyps and those experiencing loss of smell will be recruited for the study, along with healthy control participants. We will exclude individuals with unilateral nasal polyps, autoimmune diseases, ciliary disorders, cystic fibrosis, or smell loss due to tumors or trauma.
Assessments will be conducted at baseline and again three months after smell training to evaluate changes in olfactory function. Control patients will only undergo baseline testing with no follow-up assessments needed.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: John O'Neill
- Número de telefone: 4405062611
- E-mail: ONEILLJ2@ccf.org
Estude backup de contato
- Nome: Christopher Novicky
- Número de telefone: 216-444-7018
- E-mail: novickc@ccf.org
Locais de estudo
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Recrutamento
- The Cleveland Clinic
-
Contato:
- John O'Neill
- Número de telefone: 4405062611
- E-mail: ONEILLJ2@ccf.org
-
Contato:
- Hana Rosen
- Número de telefone: 216-444-7018
- E-mail: rosenh@ccf.org
-
Investigador principal:
- Mohamad Chaaban
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age less than 18 years-old
- Present to rhinology clinic with CRS with nasal polyps
- Sense of smell loss for any reason (other than trauma or tumor)
Exclusion Criteria:
- Patients < 18 years of age
- Individuals with unilateral nasal polyps
- Autoimmune diseases
- Ciliary disorders
- Cystic fibrosis
- Smell loss due to tumors or trauma
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)
Loss of smell + CRS with nasal polyps (CRSwNP)
|
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
|
|
Comparador Ativo: Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training
Loss of smell + CRS with nasal polyps (CRSwNP) - undergo 3 months of smell training
|
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
|
|
Sem intervenção: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
|
|
|
Sem intervenção: Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
Prazo: Baseline
|
At baseline, participants will complete the University of Pennsylvania Smell Identification Test (UPSIT), a standardized 40-item scratch-and-sniff odor identification test. Scores range from 0 to 40, with higher scores indicating better olfactory function. Unit of Measure: Score on a scale from 0 to 40. |
Baseline
|
|
Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
Prazo: Baseline
|
At baseline, participants will complete the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), which measures the negative psychosocial impact of olfactory dysfunction. Scores range from 0 to 48, with higher scores indicating greater negative impact of smell loss on quality of life. Unit of Measure: Score on a scale from 0 to 48. |
Baseline
|
|
Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
Prazo: Baseline
|
At baseline, participants will complete the Mini-Mental State Examination (MMSE), an 11-question cognitive screening tool. Scores range from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: Score on a scale from 0 to 30. |
Baseline
|
|
Primary Outcome Measure 4: Baseline nasal cytokine concentration
Prazo: Baseline
|
At baseline, nasal secretions will be collected from the middle meatus using a polyvinyl alcohol (PVA) sponge and analyzed for cytokine concentrations by multiplex immunoassay. Each cytokine concentration will be reported separately and will not be combined with questionnaire or cognitive assessment scores. Unit of Measure: pg/mL for each cytokine concentration reported separately. |
Baseline
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
Prazo: Baseline to Month 3
|
Change from baseline to Month 3 in olfactory function will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT), a standardized 40-item scratch-and-sniff odor identification test.
Scores range from 0 to 40, with higher scores indicating better olfactory function.
Unit of Measure: Change in score on a scale from 0 to 40.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 2: Change from baseline to Month 3 in quality-of-life impact of olfactory dysfunction measured by QOD-NS score
Prazo: Baseline to Month 3
|
Change from baseline to Month 3 in the negative psychosocial impact of olfactory dysfunction will be assessed using the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS).
Scores range from 0 to 48, with higher scores indicating greater negative impact of smell loss on quality of life.
Unit of Measure: Change in score on a scale from 0 to 48.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
Prazo: Baseline to Month 3
|
Change from baseline to Month 3 in cognitive function will be assessed using the Mini-Mental State Examination (MMSE), an 11-question cognitive screening tool.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
Unit of Measure: Change in score on a scale from 0 to 30.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
Prazo: Baseline to Month 3
|
Change from baseline to Month 3 in nasal cytokine concentration will be assessed.
Nasal secretions will be collected from the middle meatus using a polyvinyl alcohol (PVA) sponge and analyzed by multiplex immunoassay.
Each cytokine concentration will be reported separately.
Unit of Measure: Change in pg/mL.
|
Baseline to Month 3
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamad Chaaban, MD, The Cleveland Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Condições Patológicas, Anatômicas
- Doenças Respiratórias
- Doenças do Nariz
- Doenças Otorrinolaringológicas
- Distúrbios da Sensação
- Pólipos
- Distúrbios do olfato
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Anosmia
- Pólipos nasais
- Terapêutica
- Treinamento olfativo
Outros números de identificação do estudo
- IRB #24-1122
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .