Healthful Diets and Risk of Hearing Loss

• ClinicalTrials.gov Identifier: NCT03351023
• Recruitment Status: Completed
• First Posted: November 22, 2017
• Last Update Posted: November 22, 2017
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Gary C Curhan, Brigham and Women's Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Hearing Loss	Other: no intervention-this was an observational study

Study Design

• Study Type: Observational
• Actual Enrollment: 70966 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Healthful Dietary Patterns and Risk of Hearing Loss in Women
• Actual Study Start Date: July 1, 1991
• Actual Primary Completion Date: June 30, 2013
• Actual Study Completion Date: June 30, 2013

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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).

Eligibility Criteria

• Ages Eligible for Study: 27 Years to 66 Years (Adult, Older Adult)
• Sexes 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.

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

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

More Information

• Responsible Party: Gary C Curhan, Professor of Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03351023
• Other Study ID Numbers: 2007P000876
• First Posted: November 22, 2017
• Last Update Posted: November 22, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases