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Trial record 1 of 1 for:    NCT02699463
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Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study

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ClinicalTrials.gov Identifier: NCT02699463
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
ResMed

Brief Summary:
The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild OSA.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: Continous Positive Airway Pressure Other: Control Group Not Applicable

Detailed Description:

Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).

At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.

After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study
Study Start Date : December 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Continous Positive Airway Pressure
Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial
Device: Continous Positive Airway Pressure
CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA
Other Name: CPAP

Placebo Comparator: Control Group
Participants will receive standard care (Sleep hygiene counseling) during the study.
Other: Control Group
Standard sleep hygiene counseling as per published guidelines




Primary Outcome Measures :
  1. Change in quality of life using the SF-36 questionnaire [ Time Frame: 3 months ]
    Point change in energy and vitality component of questionnaire compared with control group after three months CPAP usage



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study Inclusion Criteria

  • Aged ≥ 18 and ≤ 80
  • Ability and willingness to provide written informed consent
  • AHI ≤ 15 as per AASM 2007 scoring criteria
  • Ability to tolerate a CPAP one hour long run in test

Exclusion Criteria:

  • The presence of unstable cardiac disease
  • Inability to give fully informed consent
  • Supplemental oxygen
  • Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome
  • ESS ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff
  • BMI ≥ 40

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699463


Locations
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United Kingdom
Freeman Hospital
Newcastle upon Tyne, Newcastle, United Kingdom
Blackpool Teaching Hospital
Blackpool, United Kingdom
Papworth Hospital
Cambridge, United Kingdom
Tayside Health Board, Ninewells Hospital
Dundee, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Royal Brompton Hospital, Imperial College London
London, United Kingdom, SW3 6NP
Guys & St Thomas Hospital
London, United Kingdom
Oxford Centre for Respiratory Medicine
Oxford, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Taunton and Somerset Hospital
Taunton, United Kingdom
Sponsors and Collaborators
ResMed
Investigators
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Principal Investigator: Mary Morrell, Prof Imperial College London
  Study Documents (Full-Text)

Documents provided by ResMed:
Study Protocol  [PDF] November 27, 2018
Statistical Analysis Plan  [PDF] September 25, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT02699463    
Other Study ID Numbers: MA200216
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases