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临床试验/NCT07221123
NCT07221123招募中2 期

A Feasibility and Acceptability Study Testing Two Types of Smell Exposure Interventions in Middle-Aged Older Adults With HIV

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月2日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
80
试验地点
1
主要终点
FEASIBILITY & ACCEPTABILITY

研究概览

简要总结

The goal of this study is to examine two types of olfactory interventions (conventional olfactory training vs scented marker training) in adults with HIV.

The two research questions are:

  1. Determine if participants find the intervention acceptable and assess feasibility of the study.
  2. Determine if the intervention improves olfactory function and cognitive function.

Participants will come to our office and be administered the baseline battery of questions including olfactory and cognitive performance tests. Then they will be randomized and sent home with one of the two interventions (below) in which they will engage in it for 8 weeks, after which they come back to our office for the posttest battery of questions including olfactory and cognitive performance test.

  1. Conventional Olfactory Training at Home -- 4 scents in which they will smell twice a day for 8 weeks.
  2. Scented Marker Training at Home -- Several marker scents in which they will smell twice a day for 8 weeks.

详细描述

Overall A pre-post two-group experimental design will be used. Participants will be recruited from the UAB 1917 HIV/AIDS Clinic which has a patient population of +3,900 and is the largest HIV medical provider within 100 miles. Participants will be recruited via two ways: 1) flyers posted in the UAB 1917 HIV/AIDS Clinic and 2) via 1917/CINIC participant list of participants who indicated and consented they are would like to be called for recruitment to studies (a technique used before and approved in other UAB IRB studies). Eligible participants will be consented at the UAB where a ~2 hr baseline assessment will be administered. Stratified random assignment will ensure an equal number of participants in each group by gender and smoking status. Men tend to have more olfactory dysfunction than women; therefore, it is important to control for gender upfront in the methodology. After training, participants will complete a posttest assessment.

Recruitment and Retention Procedures

Flyers. Flyers advertising the study will be provide to the UAB 1917 Clinic which they can hang or post electronically on their monitors.

Electronic Medical Record Query Using CNICS EMR Data Eligibility queries may be conducted using the CFAR Network of Integrated Clinical Systems (CNICS) EMR data. Specifically, CNICS participants (which comprise over 90% of UAB 1917 Clinic patients) have consented to be contacted to gauge interest in future studies. The Research Informatics Services Center (RISC) will provide us a list of patients meeting basic criteria (e.g., based on age, last clinic data, free from major comorbidities), and the investigators will then contact participants directly and tell them about the study and screen them over the phone as the investigators are doing in another active study protocol (RISC - IRB-300008740). When the study concludes, the investigators will also utilize RISC to yield a CNICS dataset for enrolled participants which will include basic health and HIV data (e.g., viral load).

Telephone Screen A brief telephone screening interview will be used to ensure that participants meet study inclusion/exclusion criteria. If participants meet entry criteria, they will be scheduled for a visit; appointment letters will indicate that if they develop a cold, flu, or other condition causing nasal obstruction in the interim, their appointment will be rescheduled. The appointment letter will instruct participants to refrain from eating highly aromatic foods (e.g., garlic) and abstain from liquor within 24 hrs of the appointment since these could affect olfactory tests. Thus, participants will review a signs and symptoms checklist to ensure they still meet study criteria. If they indicate they do not currently meet study criteria, they will be encouraged to participate when their situation changes. Once eligibility is confirmed, participants will sign an IRB approved consent form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

No masking

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Participants (men & women) must be 40+ years
  • •have cognitive complaints.
  • •must be proficient in English

排除标准

  • •a sinus infection (within the past 3 months), thrush, candidiasis, pregnant, current cold or flu, hay fever, asthma, nasal allergies, opportunistic infections (including COVID-19) within the past 3 months, or current nasal obstruction condition.
  • •Participation requires ~8 weeks and in-person visits, participants living beyond 60 miles away from the center will be excluded.
  • •Participants living in unstable housing (e.g., shelter) or with significant neuro-comorbidities (e.g., schizophrenia) will be excluded.
  • •Other conditions (e.g., legally blind/deaf, currently undergoing radiation or chemotherapy, or a history of significant brain trauma) that could impact olfactory and cognitive testing also necessitate exclusion.

研究组 & 干预措施

Conventional Smell Training Group

Experimental

The investigators are adopting the usual smell training approach from the literature. A standard smell training kit (i.e., MOXĒ) will be used that contains the four basic odorants across the "odor prism" - i) flowery (e.g., rose), ii) resinous (e.g., eucalyptus), iii) aromatic (e.g., cloves), and iv) fruity (e.g., lemon). Participants will be instructed to sniff each of the odorant vials/bottles for 10-20 seconds twice a day (morning and evening), for the next 8 weeks. A structured daily diary will be provided for them to record observations of the experience, memories the odorants may evoke, and any side effects experienced (i.e., headache, euphoria, light headedness, phantosmia, nasal irritation).

干预措施: Conventional Smell Training Group (Other)

Scented Marker Group

Experimental

The investigators are adopting the store bought scented markers for the smell training approach. There are several different scents in this marker set (i.e., cherry, grape, etc.). Participants will be instructed to sniff 4 makers of their choosing for 10-20 seconds twice a day (morning and evening), for the next 8 weeks. A structured daily diary will be provided for them to record observations of the experience, memories the odorants may evoke, and any side effects experienced (i.e., headache, euphoria, light headedness, phantosmia, nasal irritation).

干预措施: Scented Marker Group (Other)

结局指标

主要结局

FEASIBILITY & ACCEPTABILITY

时间窗: From enrollment to the end of treatment at 8 weeks

A training diary will be given to participants to help them keep track of their engagement in the protocol. It will have simple check boxes for ease of use as well as space to write comments/observations. Participants will also receive a weekly call from the Principal Investigator/Research Assistant and be asked to recall how many days in the past seven have they engaged in the intervention as directed; field notes will be taken to document protocol processes that aid or interfere with the study. In addition, daily text messages Monday-Friday will be sent as reminders to encourage use of the Smell Training/Smell Exposure protocol. At the Posttest Visit after use of the Smell Exposure protocols, participants will also be asked a series of questions about what they liked and did not like about using the smelling training protocols. Many of these questions are open-ended and will be coded and used in qualitative analyses.

次要结局

  • COGNITION _ Trail Making Test B(From enrollment to the end of treatment at 8 weeks)
  • OLFACTION(From enrollment to the end of treatment at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Vance, PhD

University Professor

University of Alabama at Birmingham

研究点 (1)

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