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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：John O'Neill
- 電話番号：4405062611
- メール：ONEILLJ2@ccf.org
研究連絡先のバックアップ
- 名前：Christopher Novicky
- 電話番号：216-444-7018
- メール：novickc@ccf.org
研究場所
-
-
Ohio
-
Cleveland、Ohio、アメリカ、44195
- 募集
- The Cleveland Clinic
-
コンタクト：
- John O'Neill
- 電話番号：4405062611
- メール：ONEILLJ2@ccf.org
-
コンタクト：
- Hana Rosen
- 電話番号：216-444-7018
- メール：rosenh@ccf.org
-
主任研究者：
- Mohamad Chaaban
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：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.
|
|
介入なし：Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
|
|
|
介入なし：Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Mohamad Chaaban, MD、The Cleveland Clinic
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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