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Clinical Trials/ISRCTN51740863
ISRCTN51740863
Completed
未知

Positional therapy for obstructive sleep apnoea: a randomised controlled trial to assess the effect on health and wellbeing in older and younger people

Royal Brompton & Harefield NHS Foundation Trust0 sites120 target enrollmentOctober 2, 2019
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ConditionsObstructive sleep apnoeaRespiratorySleep apnoea

Overview

Phase
未知
Intervention
Not specified
Conditions
Obstructive sleep apnoea
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Enrollment
120
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 2, 2019
End Date
November 30, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged \> \= 18 years
  • •2\. Ability and willingness to provide informed consent
  • •3\. AHI \> 5 events/hour (AASM 2012 scoring criteria) with events occurring at a frequency of 2:1 when supine, compared to non\-supine; total % supine sleep \> 20, \< 90% of total sleep; central apnoeas \< 20% total apnoeas; recording of \> \= 4 hours of analysable signals
  • •4\. Ability to fit and tolerate wearing the device around the neck during treatment demonstration and initiation

Exclusion Criteria

  • •1\. Unstable cardiac disease
  • •2\. Cardiac arrhythmia corrected with an artificial pacemaker
  • •3\. Supplemental oxygen
  • •4\. Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, Obesity Hypoventilation Syndrome; or shift workers
  • •5\. Concerns about sleepy driving or any other potentially dangerous symptom from physician
  • •6\. BMI \> \= 40 kg/m2
  • •7\. Inability to sleep in a non\-supine position
  • •8\. Skin sensitivity or an open wound around neck
  • •9\. Neck circumference \< 12inches (30cm) or \> 22inches (55cm)
  • •10\. Tics or tremors of the head

Outcomes

Primary Outcomes

Not specified

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