SOUND Trial

How it works

Dosage & preparation

Risks & contraindications

Comparisons

Background

Highlighted claims

• The SOUND trial is a two-arm, single-blinded, parallel-group RCT conducted at Peking University First Hospital in Beijing, China. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• Both the intervention and control arms receive bilateral hearing aid fitting, allowing the trial to isolate the net effect of the behavioural adherence component. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• The trial targets 150 participants aged 60–85 years with concurrent hearing loss and MCI, with a sample size inflated from 64 per arm to 75 per arm to accommodate a 15% dropout rate. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• The primary analysis follows the intent-to-treat principle using last observation carried forward for missing data, with a difference-in-difference approach for comparing cognitive function change. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• SOUND is described as the first RCT worldwide to examine the effect of a family-supported, theory-driven HAU behaviour intervention on cognitive outcomes in older adults with concurrent hearing loss and high dementia risk. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• Participant blinding is not feasible given the nature of the control condition, introducing potential performance bias. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial
• The 4-month follow-up may be insufficient to detect cognitive change, as some evidence suggests longer periods are needed. — Family-supported hearing aid use behaviour intervention to improve outcomes in older adults at high risk for dementia (SOUND): study protocol for a randomised controlled trial