Sleep-disordered Breathing Database
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Free Hospital NHS Foundation Trust
About this trial
The goal of this study is to collect clinical data on patients who have had a sleep study and are given a diagnosis of a sleep related breathing disorder such as obstructive sleep apnoea. Collecting this data in an organised way will mean that the investigators can monitor patients and their health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18 years
Referred to Royal Free London NHS Foundation Trust Sleep and Ventilation Service
Agreed to undertake a sleep study
Disqualifiers
Inability to consent
Trial population
The patient population will be those patients under the sleep and ventilation service who have undertaken a sleep study and started on treatment for their sleep disordered breathing
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Sleep disordered breathing
Trial outcomes
Primary outcomes
1
Number of patients consenting to participation in a database
From the whole cohort referred for a sleep study, the number of participants (percentage of the whole cohort) who sign a consent form and have data recorded will be calculated
Time frame
5 yearsSecondary outcomes
1
Changes in symptoms and disease related variables
Changes in symptom based scores - Epworth sleepiness score between baseline and follow up Changes in disease parametrics including: AHI (apnoea/hypopnoea index), blood gas measurements (PO2, PCO2, pH, HCO3), lung function between baseline and follow up Additional variables may be added over the duration of the database
Time frame
5 years initially, further ethical approval will be sought at 5 years to extend the database furtherSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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