NCT07402603

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
114mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Jan 2036

First Submitted

Initial submission to the registry

January 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2031

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2036

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

January 13, 2026

Last Update Submit

February 4, 2026

Conditions

Obstructive Sleep Apnoea (OSA)Hypoventilation Syndrome

Keywords

databaseobservational

Outcome Measures

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

    5 years

Secondary Outcomes (1)

  • Changes in symptoms and disease related variables

    5 years initially, further ethical approval will be sought at 5 years to extend the database further

Study Arms (1)

Sleep disordered breathing

Patients who are referred for a sleep study to investigate sleep disordered breathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free London NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Swapna Mandal, PhD

CONTACT

+442077940500swapnamandal@nhs.net

Amar Shah, PhD

CONTACT

+442077940500amar.shah5@nhs.net

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2026

First Posted

February 11, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 14, 2031

Study Completion (Estimated)

January 1, 2036

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

GB(1)