Trial Outcomes & Findings for Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study (NCT NCT02699463)
NCT ID: NCT02699463
Last Updated: 2021-01-26
Results Overview
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.
COMPLETED
NA
301 participants
3 months
2021-01-26
Participant Flow
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.
Participant milestones
| Measure |
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
|
Control Group
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
118
|
|
Overall Study
COMPLETED
|
100
|
109
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
Reasons for withdrawal
| Measure |
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
|
Control Group
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Baseline characteristics by cohort
| Measure |
Continous Positive Airway Pressure
n=115 Participants
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
|
Control Group
n=118 Participants
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
105 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-white
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Continous Positive Airway Pressure
n=115 Participants
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
|
Control Group
n=118 Participants
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
|---|---|---|
|
Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire
|
7.5 score on a scale
Interval 6.0 to 9.0
|
0 score on a scale
Interval -1.5 to 1.5
|
Adverse Events
Continous Positive Airway Pressure
Control Group
Serious adverse events
| Measure |
Continous Positive Airway Pressure
n=115 participants at risk
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
|
Control Group
n=118 participants at risk
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.87%
1/115 • Number of events 1 • 3 months
|
0.00%
0/118 • 3 months
|
|
Cardiac disorders
hospitalization for dizziness, existing cardiac condition
|
0.00%
0/115 • 3 months
|
0.85%
1/118 • Number of events 1 • 3 months
|
|
Cardiac disorders
symptoms of transient ischemic attack (TIA)
|
0.00%
0/115 • 3 months
|
0.85%
1/118 • Number of events 1 • 3 months
|
Other adverse events
| Measure |
Continous Positive Airway Pressure
n=115 participants at risk
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
|
Control Group
n=118 participants at risk
Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines
|
|---|---|---|
|
Cardiac disorders
dizziness
|
2.6%
3/115 • Number of events 4 • 3 months
|
0.00%
0/118 • 3 months
|
|
General disorders
exacerbation of pre-existing condition
|
1.7%
2/115 • Number of events 2 • 3 months
|
6.8%
8/118 • Number of events 8 • 3 months
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.00%
0/115 • 3 months
|
0.85%
1/118 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
physical accident
|
0.00%
0/115 • 3 months
|
2.5%
3/118 • Number of events 3 • 3 months
|
|
Infections and infestations
virus
|
3.5%
4/115 • Number of events 4 • 3 months
|
0.85%
1/118 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place