Boosting Olfactory and Sensory Training Study (BOOST)

NCT07221123 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: IRB - 300013575UAB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to examine two types of olfactory interventions (olfactory training vs overnight odor diffuser) in adults with HIV. The two research questions are:

1. 1.Determine if participants find the intervention acceptable and assess feasibility of the study.
2. 2.Determine if the intervention improves olfactory function and cognitive function.
3. 3.Olfactory Training at Home -- 4 scents in which they will smell twice a day for 8 weeks.
4. 4.Overnight Diffuser Group -- a single scent diffuser that participants will turn on while they sleep and use for 8 weeks.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIV

Outcome Measures

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.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

• OLFACTION

  From enrollment to the end of treatment at 8 weeks

• COGNITION

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Standard Smell Training Group

EXPERIMENTAL

We are adopting the usual smell training approach from the literature.23-32 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: Standard Smell Training Group

Overnight Diffuser Group

EXPERIMENTAL

This group will received a odorant diffuser and 7 essential oil odorant (rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender) from the Essential Oil Company (Portland, OR). Participants will receive instruction on how to set it up, and with a diary of keeping track of its use.

Other: Overnight Diffuser Grou

Interventions

Standard Smell Training Group OTHER

We are adopting the usual smell training approach from the literature.23-32 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).

Also known as: olfactory training, smell training

Standard Smell Training Group

Overnight Diffuser Grou OTHER

This group will received a odorant diffuser and 7 essential oil odorant (rose, orange, eucalyptus, lemon, peppermint, rosemary, and lavender) from the Essential Oil Company (Portland, OR). Participants will receive instruction on how to set it up, and with a diary of keeping track of its use.

Also known as: aromotherapy, smell training

Overnight Diffuser Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Related Publications (5)

• Kamath V, Del Bene VA, Collette C, Jacob A, Fazeli PL, Vance DE. A Pilot Study of Self-Rated and Psychophysical Olfactory Dysfunction in Men Living with HIV. Chemosens Percept. 2022;15(2):175-184. doi: 10.1007/s12078-022-09305-x. Epub 2022 Nov 10.

  PMID: 36406043 RESULT

• Vance D, Burrage J. Chemosensory declines in older adults with HIV: identifying interventions. J Gerontol Nurs. 2006 Jul;32(7):42-8. doi: 10.3928/00989134-20060701-06.

  PMID: 16863045 RESULT

• Vance DE, Del Bene VA, Kamath V, Frank JS, Billings R, Cho DY, Byun JY, Jacob A, Anderson JN, Visscher K, Triebel K, Martin KM, Li W, Puga F, Fazeli PL. Does Olfactory Training Improve Brain Function and Cognition? A Systematic Review. Neuropsychol Rev. 2024 Mar;34(1):155-191. doi: 10.1007/s11065-022-09573-0. Epub 2023 Feb 2.

  PMID: 36725781 RESULT

• Vance DE, Cody SL, Nicholson WC, Cheatwood J, Morrison S, Fazeli PL. The Association Between Olfactory Function and Cognition in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e144-e155. doi: 10.1097/JNC.0000000000000086.

  PMID: 31259847 RESULT

• Vance DE, Cody SL, Nicholson C, Cheatwood J, Morrison S, Fazeli PL. Olfactory Dysfunction in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):e19-e30. doi: 10.1097/JNC.0000000000000061.

  PMID: 30676359 RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

David E Vance, PhD

CONTACT

1205-934-7589; devance@uab.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Model Details: This feasibility study employs a 2-group pre-post experimental design of 80 middle-aged (40+) and older adults with cognitive complaints including: 1) a home-based Smell Training Group consisting of 8 weeks of engaging in smelling four odorants 2x/day (enroll 40, n=30 with attrition); and 2) a home-based Overnight Diffuser Group consisting of 8 weeks of engaging in using scent diffuser while one sleeps (enroll 40, n=30 with attrition)

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 27, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)