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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continous Positive Airway Pressure | Active Comparator | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial |
|
| Control Group | Placebo Comparator | Participants will receive standard care (Sleep hygiene counseling) during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continous Positive Airway Pressure | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire | The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible. | 3 months |
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Study Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Morrell, Prof | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Freeman Hospital | Newcastle upon Tyne | Newcastle | United Kingdom | |||
| Blackpool Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31806413 | Derived | Wimms AJ, Kelly JL, Turnbull CD, McMillan A, Craig SE, O'Reilly JF, Nickol AH, Hedley EL, Decker MD, Willes LA, Calverley PMA, Benjafield AV, Stradling JR, Morrell MJ; MERGE trial investigators. Continuous positive airway pressure versus standard care for the treatment of people with mild obstructive sleep apnoea (MERGE): a multicentre, randomised controlled trial. Lancet Respir Med. 2020 Apr;8(4):349-358. doi: 10.1016/S2213-2600(19)30402-3. Epub 2019 Dec 2. |
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301 participants were randomised. 233 patients formed the primary analysis group. Of those, 115 were allocated to the CPAP group and 118 were allocated to standard care. The remaining 68 patients were not analysed as part of the primary analysis but were analysed for secondary analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continous Positive Airway Pressure | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2018 | Sep 25, 2019 |
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| Control Group | Other | Standard sleep hygiene counseling as per published guidelines |
|
| 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 | SW3 6NP | United Kingdom |
| 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 |
| FG001 |
| Control Group |
Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continous Positive Airway Pressure | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial 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 |
| BG001 | Control Group | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire | The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible. | Posted | Mean | 95% Confidence Interval | score on a scale | 3 months |
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3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continous Positive Airway Pressure | Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial 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 | 0 | 115 | 1 | 115 | 9 | 115 |
| EG001 | Control Group | Participants will receive standard care (Sleep hygiene counseling) during the study. Control Group: Standard sleep hygiene counseling as per published guidelines | 0 | 118 | 2 | 118 | 13 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| hospitalization for dizziness, existing cardiac condition | Cardiac disorders | Systematic Assessment |
| ||
| symptoms of transient ischemic attack (TIA) | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Cardiac disorders | Systematic Assessment |
| ||
| exacerbation of pre-existing condition | General disorders | Systematic Assessment |
| ||
| pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| ||
| physical accident | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| virus | Infections and infestations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Alison Wimms | ResMed Ltd | +61 8884 1123 | alison.wimms@resmed.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 25, 2019 | Nov 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| Male |
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| non-white |
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