NCT05432102

Brief Summary

This study looks at the quality of the common mechanisms used to diagnose obstructive sleep apnoea (OSA) by patients in their own homes. These are pulse oximetry as a stand alone measurement and multi-channel respiratory studies that measure oximetry but also record some combination of signals including airflow at the mouth and or nose, chest and abdominal expansion, body position and snoring. This study will examine the patient acceptability of these methods and the proportion of studies that achieve various levels of technical quality ranging from a full night with all data available to a completely failed study and categories in between.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

June 20, 2022

Last Update Submit

June 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satisfactory sleep studies

    The proportion of home studies to diagnose sleep apnoea that are satisfactory without disruption to the patient's sleep or loss of signals to an extent that make the results unreliable.

    3 months

Secondary Outcomes (2)

  • Extent of sleep disruption

    3 months

  • Extent of signal failure

    3 months

Study Arms (2)

Participants having respiratory polygraphy

This label will used to describe participants having respiratory polygraphy at Royal Papworth Hospital over a 3 month period.

Diagnostic Test: Respiratory polygraphy

Participants having pulse oximetry

This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.

Diagnostic Test: Pulse oxymetry

Interventions

Pulse oxymetryDIAGNOSTIC_TEST

Diagnostic intervention to diagnose OSA.

Participants having pulse oximetry
Respiratory polygraphyDIAGNOSTIC_TEST

Diagnostic intervention to diagnose OSA.

Participants having respiratory polygraphy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing a home sleep study at Royal Papworth Hospital

You may qualify if:

  • Patient able to provide assent by completion of the Research Questionnaire Adult patients (≥ 18 years of age) Patients undergoing a home sleep study

You may not qualify if:

  • Patients unable to complete questionnaires due to language or other barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

June 27, 2022

Study Start

May 4, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations