Boosting Olfactory and Sensory Training Study (BOOST)
ConditionHIV (Human Immunodeficiency Virus)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants (men & women) must be 40+ years
have cognitive complaints.
must be proficient in English
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional Smell Training Group
Other interventionThe 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 interventionThe 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).
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Conventional Smell Training GroupExperimental treatment 1 intervention
Group B: Scented Marker GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
FEASIBILITY & ACCEPTABILITY
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.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
OLFACTION
University of Pennsylvania Smell Identification Test (UPSIT) - The UPSIT is to smell as an eye chart is to vision and has been used extensively in the literature.115,116 Age and gender-based norms from 4,000 men and women over the lifespan have provided a percentile rank of how each participant, based on his/her sex and age, performs along a normal distribution. The UPSIT is composed of 40 test items containing 40 microencapsulated "scratch and sniff" odors. This test-retest for UPSIT is very reliable (r = 0.94). (10 min.) Taste and Smell Questionnaire - Heald et al. (1998) used a smell and taste questionnaire for adults with HIV. The taste section consists of nine questions that address changes in the way food tastes. The smell section consists of five questions that address changes in the sense of smell. This measure was found to be related to the SF-36 (below) mental health and physical health summaries (p\<.01). (50 min.)
Time frame
From enrollment to the end of treatment at 8 weeks2
COGNITION _ Trail Making Test B
The investigators are using standardized pencil and paper tests of cognitive functioning such as Trails Making Test B. This measure of executive functioning is measured in seconds required to connecting the alternating dots correctly. Lower scores (seconds) indicate better cognitive functiioning.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
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Source ClinicalTrials.gov