NCT Number: NCT03351023
Healthful Diets and Risk of Hearing Loss
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.
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Notify MeKey information
Conditions
Age range
27 year–66 year
Sex eligibility
Female
Study type
Observational
Who can participate
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Hearing loss
Time frame: 1991-2013
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?"
Secondary outcomes
-
hearing loss in HSSQ
Time frame: 1991-2013
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).
Sponsors and collaborators
Lead sponsor
Brigham and Women's Hospital
Other
Registry information
Official study title
Healthful Dietary Patterns and Risk of Hearing Loss in Women
Important dates
- Study start
- 1991
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Nov 22, 2017
- Registry last updated
- Nov 22, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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