Obstructive Sleep Apnea
Conditions
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.
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.
Interventions
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
OTHERControl Group
Standard sleep hygiene counseling as per published guidelines
Sponsors
ResMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire | 3 months | 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. |
Countries
United Kingdom
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 115 |
| Control Group Participants will receive standard care (Sleep hygiene counseling) during the study.
Control Group: Standard sleep hygiene counseling as per published guidelines | 118 |
| Total | 233 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 8 |
| Overall Study | Withdrawal by Subject | 4 | 1 |
Baseline characteristics
| Characteristic | Continous Positive Airway Pressure | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 50.6 years STANDARD_DEVIATION 11.3 | 50.2 years STANDARD_DEVIATION 12.1 | 50.4 years STANDARD_DEVIATION 11.7 |
| Race/Ethnicity, Customized non-white | 10 Participants | 15 Participants | 25 Participants |
| Race/Ethnicity, Customized white | 105 Participants | 103 Participants | 208 Participants |
| Sex: Female, Male Female | 34 Participants | 37 Participants | 71 Participants |
| Sex: Female, Male Male | 81 Participants | 81 Participants | 162 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 118 |
| other Total, other adverse events | 9 / 115 | 13 / 118 |
| serious Total, serious adverse events | 1 / 115 | 2 / 118 |
Outcome results
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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Continous Positive Airway Pressure | 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 |
| Control Group | Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire | 0 score on a scale |
p-value: <0.01ANCOVA