Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04071860
Other study ID # P02423
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 9, 2019
Est. completion date July 31, 2021

Study information

Verified date September 2022
Source Papworth Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sleep apnoea (SA) is a common condition in adults and children that causes disturbed sleep and daytime symptoms. It is characterised by disrupted breathing with disturbed sleep patterns. In adults this can lead to dangerous daytime sleepiness affecting for example driving performance. In children it may lead to hyperactivity in the day and poor school performance. There are a number of techniques for diagnosing the disorder but they can affect the quality of sleep which sometimes makes them inaccurate. Most are unsuitable for small children who cannot understand the value of the tests and tend to remove the monitoring wires and devices in the night. This study aims to validate a new non contact device "Safescan", based on low power radar technology, which can be put under a bed and record breathing patterns with no measuring device in contact with the sleeper. In this initial study the device will be validated in adults, against the gold standard of polysomnography (PSG) in the sleep laboratory at Royal Papworth Hospital.


Recruitment information / eligibility

Status Completed
Enrollment 445
Est. completion date July 31, 2021
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged 18 years or older - Able to give informed consent Exclusion Criteria: - Patient with known sleep disordered breathing using a treatment device (e.g. continuous positive airway pressure) on the night of the study. - Polysomnography study records less than 4 hours of respiratory data

Study Design


Locations

Country Name City State
United Kingdom Royal Papworth Hospital Cambridge Cambridgeshire

Sponsors (2)

Lead Sponsor Collaborator
Papworth Hospital NHS Foundation Trust Iceni Labs Ltd, Warwickshire, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement between the Apnoea hypopnea index (AHI) per hour as measured overnight by the Safescan device and by clinical polysomnography Agreement in AHI +/- 10% between Safescan device and PSG. A comparison will be made between the 2 AHI's for each participant. The proportion in whom there is an agreement within +/- 10% will be reported. overnight (8-10 hours)
Secondary Agreement between the Safescan device respiratory rate (RR) as breaths per minute overnight and RR from PSG Agreement +/- 1 breath per minute between Safescan device and PSG overnight (8-10 hours)
Secondary Agreement in recorded body position between Safescan device and PSG Percentage of 1 minute epochs during the the Safescan body position is in agreement with that of the PSG overnight (8-10 hours)
See also
  Status Clinical Trial Phase
Completed NCT01620554 - Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA) Phase 2
Not yet recruiting NCT01985347 - The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study N/A
Completed NCT01312558 - The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial N/A
Completed NCT02967536 - Investigating the Neuropathology of Obstructive Sleep Apnoea
Completed NCT02855515 - Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea N/A
Terminated NCT03127800 - Morphine in Moderate Obstructive Sleep Apnoea Phase 3
Recruiting NCT04262986 - A Brief Lifestyle Modification Programme in Overweight Subjects With Obstructive Sleep Apnoea - Needs Assessment
Completed NCT03145129 - PAIR Study-PAP And IOP Relationship: Study 2
Completed NCT02713152 - Prevalence of Obstructive Sleep Apnoea in Glaucoma N/A
Completed NCT06376305 - EndoBarrier in Obstructive Sleep Apnoea Study N/A
Completed NCT01661712 - Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea N/A
Terminated NCT01530451 - Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients Phase 3
Completed NCT02518633 - Obstructive Sleep Apnoea and Adipose Tissue Dysfunction N/A
Completed NCT01557166 - Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALEā„¢ - Sleep Apnoea Phase 3
Recruiting NCT01829854 - To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery N/A
Completed NCT01619748 - Peripheral Vascular Function in Obstructive Sleep Apnoea N/A
Completed NCT02417584 - Efficacy of PAP Therapy on Blood Pressure N/A
Not yet recruiting NCT04607343 - Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea N/A
Completed NCT01546792 - Lifestyle Intervention in Obstructive Sleep Apnoea Phase 2/Phase 3
Completed NCT00300599 - Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea N/A