Healthful Diets and Risk of Hearing Loss

Hearing Loss Clinical Trial

Official title:

Healthful Dietary Patterns and Risk of Hearing Loss in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351023
• Other study ID #: 2007P000876
• Status: Completed
• Phase: N/A
• First received: November 19, 2017
• Last updated: November 21, 2017
• Start date: July 1, 1991
• Est. completion date: June 30, 2013

Study information

• Verified date: November 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To prospectively examine the relations between adherence scores for three healthful dietary patterns, the Alternate Mediterranean diet (AMED), the Dietary Approaches to Stop Hypertension (DASH), and the Alternative Healthy Eating Index (AHEI-2010), and risk of hearing loss in the Nurses' Health Study II.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70966
• Est. completion date: June 30, 2013
• Est. primary completion date: June 30, 2013
• Gender: Female
• Age group: 27 Years to 66 Years

Eligibility

Inclusion Criteria:

• The investigators limited the study to women who provided information on their hearing on the 2009 or 2013 questionnaire.

Exclusion Criteria:

• The investigators excluded those who did not provide responses to the hearing questions on either questionnaire, reported a hearing problem that began before baseline for the current analysis (1991) or did not report date of onset, or reported cancer other than non-melanoma skin cancer. The investigators also excluded women who did not complete the baseline diet questionnaire and who had missing diet information for each subsequent time period.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Other:
• no intervention-this was an observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing loss	The primary outcome, self-reported hearing loss that was moderate or worse in severity, was determined based on responses to the 2009 and 2013 questionnaires on which participants were asked about their hearing. On the 2009 main questionnaire, participants were asked, "Do you have a hearing problem?" (no, mild, moderate, severe), and "At what age did you first notice a change in your hearing?" On the 2013 main questionnaire, participants were asked, "Which best describes your hearing?" (excellent, good, a little hearing trouble, moderate hearing trouble, deaf), and "Have you noticed a change in your hearing?" and, if the response was "Yes," "At what age did you first notice a change in your hearing?"	1991-2013
Secondary	hearing loss in HSSQ	Detailed hearing-related information was collected electronically in 2012 supplemental questionnaire from a representative subcohort of NHS II participants (n= 33,102) with and without reported hearing problems, including information on previous evaluation for hearing loss, laterality (unilateral or bilateral), and identified causes of hearing loss (e.g. ototoxic medications, ear trauma, otosclerosis, cholesteatoma, Meniere's disease, chronic ear infection). Data from the HSSQ were used to conduct sensitivity analyses using more refined case definitions (e.g. excluding known etiologies and unilateral hearing loss).	1991-2013