Boosting Olfactory and Sensory Training Study (BOOST)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07221123
Phase
PHASE2
Status
Recruiting

Conditions

  • HIV (Human Immunodeficiency Virus)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Conventional Smell Training Group — OTHER
    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).
  • Scented Marker Group — OTHER
    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).

Study Details

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.

Key Dates

Start date
May 2, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Experimental: 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 Measure

FEASIBILITY & ACCEPTABILITY [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205
David Vance, PhD
2059151707

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