Diaferia 2017.

Methods	Randomised parallel‐group study.
Participants	For this review, only theN = 49 (male) participants with OSAS Inclusion criteria: men aged 25‐65 years, BMI < 35 kg/m2, confirmed OSAS diagnosis (via polysomnographic criteria). Exclusion criteria: female gender (excluded "since hormonal decline in the menopausal phase could lead to loss of muscle mass, causing a bias in the study"), other sleep disorders, previous treatment for OSAS, serious or decompensated clinical or psychiatric medical illnesses, such as CHF, cardiomyopathy, chronic obstructive pulmonary disease, chronic active hepatitis, liver cirrhosis with severe symptoms, myasthenia gravis, demyelinating disease, motor neuron disease, depression, schizophrenia, obsessive compulsive disorder, disorder anxiety, bipolar disorder, eating disorder, attention deficit disorder, and hyperactivity; patients who used alcohol, stimulants or sedatives; and patients with grade III or IV palatine tonsils, grade II or III septal deviation, or evident micrognathia. Baseline characteristics: 0% female. Mean age 46.9 (±9.9). Mean AHI NR. Mean ESS 12. Mean BMI 28.3. Country: Brazil
Interventions	Participants were randomised to 2 of 4 study groups were considered: CPAP only (n = 27) or CPAP + myofunctional therapy (MT, n = 22). Full study had 2 additional arms: placebo myofunctional therapy (n = 24) and myofunctional therapy (n = 27) in addition to those noted above for this review. *CPAP only: standard care, including attending a PSG to determine optimal pressure of CPAP *CPAP + MT: combination of orofacial muscle training and standard CPAP treatment. [Placebo: consisted of exercises without therapeutic function (relaxation and stretching of the neck muscles). MT alone: includes soft palate, tongue, and facial muscle exercises and stomatognathic function exercises. Aimed at toning the oropharynx muscles groups, optimising muscle tension mobility, and adjusting the position of the soft tissues and movements including chewing, sucking swallowing and breathing.] Study duration: patients underwent evaluations before and after 3 months of treatment, and after 3 weeks wash‐out period.
Outcomes	CPAP usage (hours/night) at 1 week, 1 and 3 months N of adherent participants (usage ≥ 4 hours per night on 70% of nights) Sleepienss (ESS) Myofunctional evaluation (adherence to myofunctional therapy was assessed via the percentage of time spend performing exercises during the 3 months of treatment
Notes	* Only CPAP only and CPAP + Myofunctional therapy groups included in Review/meta‐analysis.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Prior to treatment, the patients were divided randomly into four groups." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved.
Allocation concealment (selection bias)	Unclear risk	Trialists provided no information regarding how sequence concealment was achieved.
Blinding (performance bias and detection bias) All outcomes	High risk	No evidence of blinding of participants, personnel or outcome assessors. Study had subjective outcomes, so knowing group assignment could influence these outcomes.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The numbers of participants randomised to each study arm are not reported
Selective reporting (reporting bias)	Low risk	NCT brief summary indicates that assessments at baseline, after treatment and after 21‐day washout would include 'use of CPAP.' Published report (Diaferia 2017) does report 1 week, 1 month and 3 month CPAP usage.
Other bias	Low risk	No baseline imbalances or reported deviations from intended intervention.
Bias arising from the randomisation process (ROB2, primary outcome)	Unclear risk	Authors report: "Prior to treatment, the patients were divided randomly into four groups." Trialists provided no information regarding random component used in sequence generation or on how sequence concealment was achieved. No baseline differences in age, age, BMI, ESS. AHI not included in baseline characteristics table or in textual description of baseline comparison across groups. The results table (5) does report AHI before and after treatment for each group. Baseline differences are present, but statistical significance was not tested. For the intervention arms of interest for our review (CPAP only, CPAP + Myofunctional therapy), those baseline differences are likely consistent with chance. Baseline differences are larger in the other two arms (control, myofunctional therapy only), but likely still consistent with chance. Minimal information provided regarding randomisation procedures. No explicit documentation regarding random component or allocation concealment.
Bias due to deviations from intended interventions (ROB2, primary outcome)	High risk	NCT01289405 trial information indicates double masking (participant, investigator). Published report indicates only, "During the clinical assessment, the evaluators were blinded." Thus, no evidence that participants or research staff were blind to intervention assignment. Morever, blinding would be difficult given the nature of the interventions. No deviations documented; none suspected based upon review. No information as to whether participants were analysed in the groups to which they were originally assigned since no information was provided as to the original randomisation Ns.
Bias due to missing outcome data (ROB2, primary outcome) All outcomes	High risk	The numbers of participants randomised to each study arm are not reported. In Results, authors write: "The flowchart of patient selection during this study started with 140 patients with 40 patients failing to complete the study. The 100 patients who finished the study protocol had been distributed to placebo group (N = 24), myofunctional therapy group (N = 27),CPAP group (N = 27), and combined group (N = 22)." There is no flowchart. Assuming 140 participants were randomised (most likely/rational scenario), a substantial proportion (28.6%) are missing outcome data. Authors provided no information regarding reasons for missing outcome data. Therefore, missingness could depend on true outcome value. The numbers of participants randomised to each study arm are not reported. Therefore, the proportions of participants with missing outcome data in each group cannot be calculated or compared to determine if differences in proportions are significant.
Bias in measurement of the outcome (ROB2, primary outcome) All outcomes	Low risk	Outcome "assessor" is CPAP device: no knowledge of allocation possible.
Bias in selection of the reported result (ROB2, primary outcome) All outcomes	Low risk	NCT01289405 description did not list CPAP adherence under planned primary or secondary outcomes at 90 day endpoint. NCT brief summary indicates that assessments at baseline, after treatment and after 21‐day washout would include 'use of CPAP.' Published report (Diaferia 2017) does report 1 week, 1 month and 3 month CPAP usage. All planned time points reported. Multiple analyses (e.g. variable adherence 'thresholds') not conducted.
Overall risk of bias (ROB2, primary outcome) Machine usage	High risk	‐