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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: John O'Neill
- 전화번호: 4405062611
- 이메일: ONEILLJ2@ccf.org
연구 연락처 백업
- 이름: Christopher Novicky
- 전화번호: 216-444-7018
- 이메일: novickc@ccf.org
연구 장소
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Ohio
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Cleveland, Ohio, 미국, 44195
- 모병
- The Cleveland Clinic
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연락하다:
- John O'Neill
- 전화번호: 4405062611
- 이메일: ONEILLJ2@ccf.org
-
연락하다:
- Hana Rosen
- 전화번호: 216-444-7018
- 이메일: rosenh@ccf.org
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수석 연구원:
- Mohamad Chaaban
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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활성 비교기: Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)
Loss of smell + CRS with nasal polyps (CRSwNP)
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Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
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활성 비교기: 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
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Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
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간섭 없음: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
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간섭 없음: Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
기간: Baseline
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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
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Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
기간: Baseline
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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
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Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
기간: Baseline
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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
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Primary Outcome Measure 4: Baseline nasal cytokine concentration
기간: Baseline
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
기간: Baseline to Month 3
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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.
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Baseline to Month 3
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Secondary Outcome Measure 2: Change from baseline to Month 3 in quality-of-life impact of olfactory dysfunction measured by QOD-NS score
기간: 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.
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Baseline to Month 3
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Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
기간: 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
|
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Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
기간: 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
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Mohamad Chaaban, MD, The Cleveland Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IRB #24-1122
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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