Healthful Diets and Risk of Hearing Loss

Healthful Dietary Patterns and Risk of Hearing Loss in Women

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Other: no intervention-this was an observational study

• Study Type: Observational
• Enrollment (Actual): 70966

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 27 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The Conservation of Hearing Study (CHEARS) examines risk factors for hearing loss among participants in the Nurses' Health Study II, an ongoing cohort study of 116,430 female registered nurses in the US, aged 25-42 at enrollment in 1989. Participants have been followed by biennial mailed questionnaires that elicit updated information on diet, lifestyle, and various health outcomes; the follow-up rate over 26 years exceeds 90% of the eligible person-time. After exclusions, a total of 70,966 women were included in the analyses.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nurses' Health Study II; Nurses' Health Study II, an ongoing cohort study of 116,430 female registered nurses in the US, aged 25-42 at enrollment in 1989. Participants have been followed by biennial mailed questionnaires that elicit updated information on diet, lifestyle, and various health outcomes; the follow-up rate over 26 years exceeds 90% of the eligible person-time.	Other: no intervention-this was an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Gary Curhan, MD, ScD, Brigham and Women's Hospital/Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 1991
• Primary Completion (Actual): June 30, 2013
• Study Completion (Actual): June 30, 2013

Study Registration Dates

• First Submitted: November 19, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2017
• Last Update Submitted That Met QC Criteria: November 21, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 2007P000876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For investigators who wish to use the investigators' data, the investigators have adopted a data enclave approach to data sharing within the Nurses' Health Study II cohort. Along with a general description of the cohorts and questionnaires that have been used since 1989 (NHS II), guidelines are available upon request for outside users to access the resources of our studies. Typically, an outside user prepares a brief proposal that is reviewed by the Channing investigator group to identify a local investigator to assist the outside investigator. If uncertainty arises as to the merit of a request, the External Advisory Committees makes a final decision. After approval, the investigators facilitate access to our data either through programming support or orientation to the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No