Patient Experience and Technical Success of Community Sleep Studies
PETSOCSS
1 other identifier
observational
200
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJune 27, 2022
June 1, 2022
2 months
June 20, 2022
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.
Participants having pulse oximetry
This label will used to describe participants having pulse oximetry at Royal Papworth Hospital over a 3 month period.
Interventions
Diagnostic intervention to diagnose OSA.
Diagnostic intervention to diagnose OSA.
Eligibility Criteria
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
- Papworth Hospital NHS Foundation Trustlead
- Iceni Laboratoriescollaborator
- CRN Easterncollaborator
Study Sites (1)
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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