- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402603
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
- Name: Swapna Mandal, PhD
- Phone Number: 23359 +442077940500
- Email: swapnamandal@nhs.net
Study Contact Backup
- Name: Amar Shah, PhD
- Phone Number: 23359 +442077940500
- Email: amar.shah5@nhs.net
Study Locations
-
-
-
London, United Kingdom
- Royal Free London NHS Foundation Trust
-
Contact:
- Swapna Mandal, PhD
- Phone Number: 23359 +442077940500
- Email: swapnamandal@nhs.net
-
-
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-WS-0157
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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