NCT07221123 · University of Alabama at Birmingham
Boosting Olfactory and Sensory Training Study (BOOST)
(BOOST)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Conventional Smell Training Group
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).
OTHER
Scented Marker Group
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).
Primary outcome measures
FEASIBILITY & ACCEPTABILITY
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants (men \& women) must be 40+ years
- have cognitive complaints.
- must be proficient in English
Exclusion criteria
- 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.
Where
- Birmingham, Alabama
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations