Sleep-disordered Breathing Database

February 4, 2026 updated by: Royal Free Hospital NHS Foundation Trust

Enhancing Patient Care: Sleep and Ventilation Database

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.

Study Overview

Status

Not yet recruiting

Detailed Description

This is a prospective database collecting: symptom, physiological, comorbidity and treatment response data

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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

Description

Inclusion Criteria:

  • Age >18 years
  • Referred to Royal Free London NHS Foundation Trust Sleep and Ventilation Service
  • Agreed to undertake a sleep study

Exclusion Criteria:

  • Inability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sleep disordered breathing
Patients who are referred for a sleep study to investigate sleep disordered breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients consenting to participation in a database
Time Frame: 5 years
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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in symptoms and disease related variables
Time Frame: 5 years initially, further ethical approval will be sought at 5 years to extend the database further
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
5 years initially, further ethical approval will be sought at 5 years to extend the database further

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

January 14, 2031

Study Completion (Estimated)

January 1, 2036

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Other researchers may apply for access to the database, provided they demonstrate a valid scientific and public benefit and meet all governance requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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