Acromegaly & Sleep Apnoea

NCT ID: NCT02371057

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 653 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-24
• Study Completion Date: 2018-02-21

Brief Summary

Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.

Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.

The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.

Conditions

Acromegaly

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

patients under follow-up known to have sleep apnoea

No interventions assigned to this group

patients attending the sleep apnoea clinic for assessment

Patients who are attending clinic who have not yet been diagnosed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults aged 16 and above.
• Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea
• Have capacity to given informed consent.

Exclusion Criteria

• Patients under 16 years of age
• Not referred to the Sleep Apnoea Clinic
• Unable to give informed consent

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

ED13/10973

Identifier Type: -

Identifier Source: org_study_id