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- Isacsson, G., et al.
(författare)
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Bibloc and Monobloc Oral appliances in the Treatment of Obstructive Sleep apnoea : a Multicenter, Randomized, Blinded, Parallel-Group Trial
- 2017
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Ingår i: Sleep Medicine. - : Elsevier. - 1389-9457 .- 1878-5506. ; 40:Suppl 1, s. E142-E143
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- Introduction: The clinical benefit of bibloc over monobloc appliances has not been established in randomized trials treating obstructive sleep apnoea (OSA). We hypothesized that the two types of appliances are equally effective in treating moderate to severe OSA. Materials and methods: We performed a blinded, multicenter, randomized, controlled, prospective, parallel-group trial including patients aged 18 years or older who had moderate-to-severe OSA. Patients were randomly assigned to receive either a bibloc or a monobloc appliance with the intention to protrude the mandible 75% of the individual maximal protrusion capacity. At baseline a one-night respiratory polygraphy was done without any respiratory support. The polygraphy was iterated with the appliance in place at a 6-week follow-up. The primary outcome was the absolute change in the apnoea-hypopnea-index (AHI) from baseline to the 6-week follow-up, analysed in the per-protocol population. All patients who received an appliance were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02148510, and approved by Uppsala Regional Ethical Review Board, Sweden (#2014/021). Results: We recruited patients from three dental specialist clinics in Sweden; enrolment of 302 patients was done between March 2014 and April 2016; 146 randomized to bibloc and 156 to monobloc appliance. Twenty-three patients in the bibloc group and 17 in the monobloc group were withdrawn due to reasons like appliance could not be fitted, lack of compliance, adverse events or non-valid follow-up polygraphy i.e. a per-protocol group of 123 bibloc and 139 monobloc treated patients. The mean change of AHI from baseline to 6 weeks of treatment was -13.8 (95% CI -16.1 to -11.5; p < 0.001) in the bibloc group and -12.5 (95% CI -14.8 to -10.3; p < 0.001) in the monobloc group. The mean difference was not significant between the groups (-1.3 (95% CI -4.5 to 1.9). The most common adverse event in the orofacial region was upper airway infection followed by complains from various parts of the mouth, jaws and teeth. Conclusions: Bibloc and monobloc appliance treatment was equal in their effects in treating OSA as measured by at home polygraphic respiratory measures and the appliances were associated with a similar degree of adverse events. Acknowledgements: Funding from Uppsala-Örebro Regional Research Council and Vastmanland County Council, Sweden.
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| 2. |
- Ekström, Magnus, et al.
(författare)
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Validation of the Swedish Multidimensional Dyspnea Profile (MDP) in outpatients with cardiorespiratory disease
- 2019
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Ingår i: BMJ Open Respiratory Research. - : BMJ. - 2052-4439. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Breathlessness is a cardinal symptom in cardiorespiratory disease. An instrument for measuring different aspects of breathlessness was recently developed, the Multidimensional Dyspnea Profile (MDP). This study aimed to validate the MDP in terms of the underlying factor structure, internal consistency, test-retest reliability and concurrent validity in Swedish outpatients with cardiorespiratory disease. Methods Outpatients with stable cardiorespiratory disease and breathlessness in daily life were recruited. Factor structure of MDP was analysed using confirmatory factor analysis; internal consistency was analysed using Cronbach's alpha; and test-retest reliability was analysed using intraclass correlation coefficients (ICCs) for patients with unchanged breathlessness between assessments (baseline, after 30-90 min and 2 weeks). Concurrent validity was evaluated using correlations with validated scales of breathlessness, anxiety, depression and health-related quality of life. Results In total, 182 outpatients with cardiorespiratory disease and breathlessness in daily life were included; 53.3% were women; main diagnoses were chronic obstructive pulmonary disease (24.7%), asthma (21.4%), heart failure (19.2%) and idiopathic pulmonary fibrosis (18.7%). The MDP total, immediate perception and emotional response scores, and individual item scores showed expected factor structure and acceptable measurement properties: internal consistency (Cronbach's alpha, range 0.80-0.93); test-retest reliability at 30-90 min and 2 weeks (ICC, range 0.67-0.91); and concurrent validity. There was no evidence of a learning effect. Findings were similar between diagnoses. Discussion MDP is a valid instrument for multidimensional measurement of breathlessness in Swedish outpatients across cardiorespiratory diseases.
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| 3. |
- Isacsson, Göran, et al.
(författare)
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Use of bibloc and monobloc oral appliances in obstructive sleep apnoea : a multicentre, randomized, blinded, parallel-group equivalence trial
- 2019
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Ingår i: European Journal of Orthodontics. - : Oxford University Press. - 0141-5387 .- 1460-2210. ; 41:1, s. 80-88
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Tidskriftsartikel (refereegranskat)abstract
- Background: The clinical benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that the two types of appliances are equally effective in treating OSA.Objective: To compare the efficacy of monobloc versus bibloc appliances in a short-term perspective.Patients and methods: In this multicentre, randomized, blinded, controlled, parallel-group equivalence trial, patients with OSA were randomly assigned to use either a bibloc or a monobloc appliance. One-night respiratory polygraphy without respiratory support was performed at baseline, and participants were re-examined with the appliance in place at short-term follow-up. The primary outcome was the change in the apnoea-hypopnea index (AHI). An independent person prepared a randomization list and sealed envelopes. Evaluating dentist and the biomedical analysts who evaluated the polygraphy were blinded to the choice of therapy.Results: Of 302 patients, 146 were randomly assigned to use the bibloc and 156 the monobloc device; 123 and 139 patients, respectively, were analysed as per protocol. The mean changes in AHI were -13.8 (95% confidence interval -16.1 to -11.5) in the bibloc group and -12.5 (-14.8 to -10.3) in the monobloc group. The difference of -1.3 (-4.5 to 1.9) was significant within the equivalence interval (P = 0.011; the greater of the two P values) and was confirmed by the intention-to-treat analysis (P = 0.001). The adverse events were of mild character and were experienced by similar percentages of patients in both groups (39 and 40 per cent for the bibloc and monobloc group, respectively).Limitations: The study shows short-term results with a median time from commencing treatment to the evaluation visit of 56 days and long-term data on efficacy and harm are needed to be fully conclusive.Conclusion: In a short-term perspective, both appliances were equivalent in terms of their positive effects for treating OSA and caused adverse events of similar magnitude.Trial registration: Registered with ClinicalTrials.gov (#NCT02148510).
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| 4. |
- Sundh, Josefin, 1972-, et al.
(författare)
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Clinical validation of the Swedish version of Dyspnoea-12 instrument in outpatients with cardiorespiratory disease
- 2019
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Ingår i: BMJ Open Respiratory Research. - : BMJ. - 2052-4439. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Breathlessness is the cardinal symptom in both cardiac and respiratory diseases, and includes multiple dimensions. The multidimensional instrument Dyspnoea-12 has been developed to assess both physical and affective components of breathlessness. This study aimed to perform a clinical validation of the Swedish version of Dyspnoea-12 in outpatients with cardiorespiratory disease. Methods Stable outpatients with cardiorespiratory disease and self-reported breathlessness in daily life were recruited from five Swedish centres. Assessments of Dyspnoea-12 were performed at baseline, after 30-90 min and after 2 weeks. Factor structure was tested using confirmatory factor analysis and internal consistency using Cronbach's alpha. Test-retest reliability was analysed using intraclass correlation coefficients (ICCs). Concurrent validity at baseline was evaluated by examining correlations with lung function and several instruments for the assessment of symptoms and health status. Results In total, 182 patients were included: with the mean age of 69 years and 53% women. The main causes of breathlessness were chronic obstructive pulmonary disease (COPD; 25%), asthma (21%), heart failure (19%) and idiopathic pulmonary fibrosis (19%). Factor analysis confirmed the expected underlying two-component structure with two subdomains. The Dyspnoea-12 total score, physical subdomain score and affective subdomain scores showed high internal consistency (Cronbach's alpha 0.94, 0.84 and 0.80, respectively) and acceptable reliability after 2 weeks (ICC total scores 0.81, 0.79 and 0.73). Dyspnoea-12 showed concurrent validity with the instruments modified Medical Research Council scale, COPD Assessment Test, European Quality of Life-Five Dimensions-Five levels, the Functional Assessment of Chronic Illness Therapy-Fatigue, the Hospital Anxiety and Depression Scale, and with forced expiratory volume in 1 s in percentage of predicted value. The results were consistent across different cardiorespiratory conditions. Conclusion The Dyspnoea-12 is a valid instrument for multidimensional assessment of breathlessness in Swedish patients with cardiorespiratory diseases.
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| 5. |
- Berling Holm, Katarina, et al.
(författare)
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Surgery for chronic otitis media causes greater taste disturbance than surgery for otosclerosis
- 2019
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Ingår i: Otology and Neurotology. - : Lippincott Williams & Wilkins. - 1531-7129 .- 1537-4505. ; 40:1, s. e32-e39
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: Patients with otosclerosis more often complain about postoperative taste disturbance than patients with chronic otitis media, which seems paradoxical. We aim to investigate if and potentially why this seems to be the case, since the chorda tympani nerve (CTN) is thought to be severely traumatized less frequently during surgery in the former than in the latter.Study Design: Prospective cohort study.Setting: Department of Otorhinolaryngology at Hospital of Vastmanland, Vasteras, Sweden.Patients: Sixty-five adults undergoing primary middle ear surgery were included. Thirty-seven were operated on for chronic suppurative otitis media with or without cholesteatoma (CSOM) and 28 for otosclerosis.Interventions: Middle ear surgery due to otosclerosis or CSOM. Subjective and objective taste measurements and quality of life (QoL) questionnaire.Main Outcome Measures: Taste was assessed using electrogustometry (EGM) and the filter paper disc (FPD) method before and up to 1 year after surgery. Questionnaires on taste disturbance, including a visual analogue scale (VAS), and QoL were completed before and up to 1 year after surgery.Results: Subjective taste disturbance anytime during the 1-year follow-up were reported by 62 and 46%, respectively. The difference in EGM 1 week after surgery compared with preoperative EGM was significantly greater among CSOM patients than otosclerosis. One year postoperatively, the difference is non-significant.Conclusion: Surgery for CSOM causes greater initial and more long-lasting taste disturbances as compared with surgery for otosclerosis. One-year postoperative taste normalizes for both CSOM and otosclerosis patients according to VAS and EGM measurements. No real change in QoL was seen 1-year postoperatively.
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| 9. |
- Sundh, Josefin, 1972-, et al.
(författare)
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REgistry-based randomized controlled trial of treatment and Duration and mortality in long-term OXygen therapy (REDOX) study protocol
- 2019
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Ingår i: BMC Pulmonary Medicine. - : BioMed Central. - 1471-2466. ; 19:1
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Long-term oxygen therapy (LTOT) during 15 h/day or more prolongs survival in patients with chronic obstructive pulmonary disease (COPD) and severe hypoxemia. No randomized controlled trial has evaluated the net effects (benefits or harms) from LTOT 24 h/day compared with 15 h/day or the effect in conditions other than COPD. We describe a multicenter, national, phase IV, non-superiority, registry-based, randomized controlled trial (R-RCT) of LTOT prescribed 24 h/day compared with 15 h/day. The primary endpoint is all-cause-mortality at 1 year. Secondary endpoints include cause-specific mortality, hospitalizations, health-related quality of life, symptoms, and outcomes in interstitial lung disease.METHODS/DESIGN: Patients qualifying for LTOT are randomized to LTOT 24 h/day versus 15 h/day during 12 months using the Swedish Register for Respiratory Failure (Swedevox). Planned sample size in this pragmatic study is 2126 randomized patients. Clinical follow-up and concurrent treatments are according to routine clinical practice. Mortality, hospitalizations, and incident diseases are assessed using national Swedish registries with expected complete follow-up. Patient-reported outcomes are assessed using postal questionnaire at 3 and 12 months.DISCUSSION: The R-RCT approach combines the advantages of a prospective randomized trial and large clinical national registries for enrollment, allocation, and data collection, with the aim of improving the evidence-based use of LTOT.TRIAL REGISTRATION: Clinical Trial registered with www.clinicaltrials.gov , Title: REgistry-based Treatment Duration and Mortality in Long-term OXygen Therapy (REDOX); ID: NCT03441204.
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