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New treatment option for Hyposmia
Official title Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial
ClinicalTrials.gov ID: NCT06600438
What this study is testing
- What it's testing
- Slow-SPEED UK is an 18-month randomised, double-blind feasibility trial evaluating the delivery, adherence, and acceptability of a digitally supported physical activity programme in community-dwelling adults aged 40 and over with objectively confirmed hyposmia (reduced sense of smell) and low baseline physical activity. Participants are randomly assigned 1:1 to either a full-dose activity-support programme (targeting a 100% increase in daily step count) or a very low-dose active control (targeting a 10% increase).
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 100
You may be able to join if
- Age ≥ 40 years
- Objective hyposmia, defined as scoring below the 15th percentile (adjusted for age/sex) on UPSIT
- Ability and willingness to provide written informed consent
- Proficiency in written and spoken English sufficient to complete study procedures.
- Willingness and ability to attend baseline (in-person), 9-month (remote), and 18-month (in-person) assessments.
You likely can't join if
- Clinical diagnosis of PD, dementia, or other neurodegenerative conditions
- Severe or unstable medical or psychiatric illness likely to impair participation
- Use of agents known to alter olfaction (e.g. intranasal zinc, chronic corticosteroids)
- Current enrolment in an treatment study within the past 3 months (standard research retention guidance).
- Inability to complete study procedures in English, per investigator assessment
- Unable to give consent
See the full eligibility criteria
- Age ≥ 40 years
- Objective hyposmia, defined as scoring below the 15th percentile (adjusted for age/sex) on UPSIT
- Ability and willingness to provide written informed consent
- Proficiency in written and spoken English sufficient to complete study procedures.
- Willingness and ability to attend baseline (in-person), 9-month (remote), and 18-month (in-person) assessments.
- Access to telephone or internet for interim communication. Specifically, in possession of a suitable smartphone (screen size minimum 4.6 inch; Android version 9 or iOS version 15 or newer).
- Physical activity threshold: During the 4-week eligibility run-in, the mean daily step count must be \<7,000 steps/day, calculated over ≥21 valid days (a valid day = ≥10 hours wear time or ≥1,000 steps). If recruitment...
- Clinical diagnosis of PD, dementia, or other neurodegenerative conditions
- Severe or unstable medical or psychiatric illness likely to impair participation
- Use of agents known to alter olfaction (e.g. intranasal zinc, chronic corticosteroids)
- Current enrolment in an treatment study within the past 3 months (standard research retention guidance).
- Inability to complete study procedures in English, per investigator assessment
- Unable to give consent
- Participants not living independently in the community. Participants in nursing homes, hospitalised persons on in a non-institutionalised setting are excluded.
- Subject's personal smartphone is Fitbit-incompatible i.e. Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite
- Activity level above threshold during eligibility run-in: mean daily step count ≥7,000 steps/day (or ≥10,000 steps/day if the broadened threshold is activated).
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.