Modalities and Treatments of Central Sleep Apnea - Research Proposal Example

Modalities and Treatments of Central Sleep Apnea Insert Insert Introduction Complex sleep apnea syndrome (CompSAS) gives the description of the coexistence as well as appearance and persistence, always associated with periodic breathing pattern (Aldrich, 1999). Formerly conducted studies have proven that that adaptive servoventilation (ASV) in the initial stages exhibits a lot of effectiveness as compared to continuous positive air pressure (CPAP). This is more evident for those patients suffering from complex sleep apnea syndrome (CompSAS), though coming up with the best therapy for this condition has been a night mare. The difficulty in choosing the best therapy gets attributed to the residual breathing systems which seems to getting resolved periodically for various patients aligned for chronic CPAP therapy (Barnes, 2006).  For the Complex sleep apnea syndrome (CompSAS) patients undergo a number of coexistence obstructive sleep apnea (OSA) and are highly evident during the period of full completion of restoring the airway patency (Carney, Berry & Geyer, 2005). For a quite a number patients diagnosed with ASV, they have experienced a lot of reduction in apnea-hypopnea index (AHI) as compared to the CPAP. Despite this, research the study has to be conducted in order to come up with the functionality of ASV versus CPAP, in matters regarding to chronic medication of CompSAS. In this proposal paper, I am going to illustrate on the best medication as well as therapy that need to get administered for those patients suffering from CompSAS. Methodology Design This particular design to be used in this medication is a prospective multicellular trial that has undergone randomization and single-blinding. The most single main objective is to make comparison as well as contrast between the ability of ASV to produce the desired results as for the same capability of CPAP. This is in line with finding the best resolution for CompSAS within a time frame of three months or rather 90-day period. By use of priori method, determination of the goal of medication can be made possible, for an AHI of lesser than 10/h. While undertaking this, there will be a projection that a relevant difference in AHI should deliver 10/h. The secondary objective will be to conduct am assessment on the impacts on the desired airway pressure (PAP) medication towards restoring as well as achieving a quality life. In this case, there should be a determination of the percentage of patients that have claimed to have realized positive changes and improvements from SDB. For these particular patients, determination needs to be made on the particular clinical parameters that can get used towards the responses of CPAP. This has to get related to the demands imposed for the medication conducted with ASV. Participants will get recruited through the use of investigator invitation as well as use of signage. This particular signage will get placed at the sleep centers where participation will be taking place. They all need to get clinical indication by the diagnostic and CPAP titration polysomnograms (PSGs). There are a number of studies that have made use of residual CAI that is either greater or equal to five, as their characteristic to use in the process of definition. In our case, we are determined to those who actively participate should have a slight greater value of CAI. Therefore in this case the value of arousal in the whole process of treatment will be greater or equal to ten. The entire participant who will express their interests will as well as meeting the established criteria will receive the consent to participate. Their PSGs will have to be sent to the Core Laboratory for the purpose of reviewing by the qualified laboratory technicians. All those candidates who will receive the confirmation of having CompSAS, they will receive a visits amounting four times. Among these visits, three will get conducted in an individual visiting the clinic and the other one will entail a phone call for the purpose of making a follow-up. This follow-up phone call will be done within a period of not more than three months, or exactly on the 90th day after the treatment. This study will get approval by the internal review boards for every centre that will be participating or rather the supplemental material. The first visit will be meant for the purpose of making confirmation on the exclusion and inclusion criteria. It will also be meant for find out the baseline Epworth Sleepiness Scale (ESS) score and the Life Index associated with Apnea Quality (SAQLI). After this, all the participants will get randomized for the treatment, through either of the two therapies; CPAP or ASV. For the particularly assigned therapy, titration will get performed for a duration of a full night of PSG and all the participants will get required to start for the therapy for the best established settings. All the procedures and methodologies, participants guidelines as well as the settings of the equipments and other tools and machinery applied during titration will have to be blinded to the participants (Epstein, & Mardon, 2007). . Fourteen days, which is two weeks, after commencing the medication all the participants will get conducted by use of phone calls, mainly for the purpose of making inquiries. The phone call will be important for the purposes of making further enquiries on the respond to the problems, and this is what visit two entails (Gay, n.d) Visit three will get conducted in individual; this means that the particular patient will have to avail his or herself. On this day, the patient will have to get served for the purposes of downloading a 30-day PAP data and come up with the required SAQLI. In this process, the medical will have to professions will get the evaluation from the participants on matters to do with the qualities of the sleep. This will be done via a visual non digital scale, also referred to as visual analog scale (VAS), improve on the relevance of adherence and look at some of the problems encountered during the process of adaptation (Guilleminault, 2005).  The next visit will be visit four and which will take place after a duration of 90 days, or exactly three months from the beginning of the medication. All the participants involved will have to complete a final PSG on their respective medication mode and settings. After this, they will complete the last PAP Comfort, ESS, and answer all the questions addressed in the SAQLI questionnaire. All the data from the PAP usage will get downloaded for the last final time. Later on, the subsequent medication after the study will get aligned for further analysis and discussion, which will get facilitated by the sleep specialist in the particular site. Measurement and Data Management Approximately three to four PSGs are needed for every participant who showed up. The PSGs in this matter will include; undertaking diagnosis and the first CAP titration PSG. The PSG will get composed of those nights considered to get split. All the useful data on PSG are recorded at the locally available sites. After this, they will get taken for further analysis and their scoring specifically done by a registered PSG technologist on matters pertaining Gamma software within the Centre for Sleep Medicine. All this recording will not just be regular but will have to follow the standardized criteria. The inter technologist scoring agreement will get taken for further testing, in a fashion that is underway, and this will have the objectivity of affirming reproducibility. There will be a need for a single board-certified sleep specialist to facilitate a, clinical review for confirmatory reasons and auditing purposes for the respective PSG. After all the reviews have gotten undertaken, all the PSG reports will get sent back to their sites and profession in the sight sleep upon reaching the agreements. The information and details in the supplement materials are related to the observations and measurements made as well as data management. The titration of CPAP and ASV are always performed with respect to the standardized protocol in the particular facility as well as the optimal mediation settings reached upon by the Core Lab. These treatment settings get determined specifically to suit the required period of three months treatment span. At the last PSG, consideration on the SDB resolving will get made, only when the AHI is lesser or equal to ten, since this will indicate absence of residual timely breathing. This will get related to the detection by the inspection of the total aggregate of respiratory impedance plethysmography. It can as well be the pressure alert from the flow generator, particularly for those participants who got medication with the ASV. Statistical Methods Randomization is done, and in this case, all the summaries made from the data will get presented for all the participants randomized to this particular medical study, as well as for those participants considered as evaluable. The evaluable set is made up of the entire participant who will make use of the study device for a period of four hours or excess in a given night. They need to be more than 70% of the nights within the three month duration of study. It is also recommended that all the participants considers evaluable, complete the last PSG at the three month visitation. Primary efficacy will get assessed and this will get done by making comparisons on the dynamism in the total AHI from the baseline diagnostic (Kushida, 2007). This baseline diagnostic will get accorded to the visit to four PSG, which will entail a three month visit, across the dual treatment sets, which is CPAP versus ASV. The post primary endpoints entails the SAQLI at three months, CompSAS resolution, and the index on arousal derived from the respiration as well as the mean daily consumption over the period of study. It also entails the assessment conducted on ESS and VAS results for the entire duration of study. Comparison between all the endpoint proves some levels of relevancy, and therefore it has to get undertaken. In some cases, the dynamism from baseline seems appropriate and hence must get assessed to improve on the validity and reliability levels of the study (Montagna, & Chokroverty, 2011). The statistical methods to get used in this case are the student t-test or the Wilcoxon rank-sum test. Therefore the generation of all the statistical comparison and contrast between the medication sets will have to get generated two-sample student t-test. On some cases, the Wilcoxon rank-sum test will get used, and this will depend on the nature of the distributions with respect to normality. In the study, there will be generation of comparisons that are categorical, and this gets done by the use of chi-Square and the Fisher exact tests, where it proves to have appropriateness. In all the situation, the values of P get based on double sided test, keeping in mind a type on error with approximation of 0.005 level of significance. All the statistical calculations get performed in the SAS, with the version of 9.2. Sample Size By use of the results from the prior study as a guideline basis, the sample size of 21 gets calculated in every set who exhibit high capabilities of detecting a variation in the aggregates of 10AHI occurrences. An important aspect to get further undertaken into account is the dropout degree or around 144 degrees or rather 40%. Over the entire study , enrollment is likely to get lower than the anticipated, and for this reason, a study rejuvenated to around 80% has a lot of sufficiency in assessing the objectives. By conducting assessment of the whole process, there will be the need of i6 evaluable members who showed up in each medical arm, for the entire 32 participants. Equipment In the study the equipment to get used is the positive air medication device which is the VPAP Adapt SV. This is a flow generator, and upon reliance on the allocation arms, setting of the devices takes place in the ASV or CPAP mode. For the purposes of enhancing comfort, the HumidAire 2i provides the best result and usage and the ResLink devices, together with the VPAP Adapt SV get used. The two when used together, they aid in the process of recording compliance as well as the data from respiratory occurrences, which are the supplemental material. Results The total number of patients undergoing the screening for the study is 140, with a total of 69 getting enrolled. There are always cases of patients withdrawing form study, and in this case we expect at least three of them. A quite a number of participants will have their body mass index getting randomized, and this can get approximated to sixty six participants while the rest thirty-six participants will get considered evaluable. For the purposes of searching for the predictors of the required response level in relation to CPAP, which is considered as achieving an AH which is lesser than ten at PSG, correlation gets undertaken. This is the correlation of the population data of all the members who showed up and got randomized into the CPAP set having AHI at the last PSG. In this case there will be no baseline clinical correlating to the AHI at the concluding PSG. The only variable that will correlate to the response from CPAP is the excessive oxygen concentration levels when the diagnostic study will get on course. Discussion A number of scholars have raised concerns on the complex disordered breathing patterns, and this has resulted into debates concerning the most optimal treatment that need to get undertaken or adopted to these patients. A number of studies have proved that, for those patients suffering from CompSAS, CPAP is giffen to those devices equipped with adaptive servo technology (Randerath, Sanner & Somers, 2006). This is more evident when it comes to controlling the sleep disordered breathing. This diagnostic study contributes important information to this debate. In our study, which entails a randomized, one –blind that took place for duration of three months, the best treatment mode gets revealed. The study will show that the application of the use of ASV results into a more significant control of the entire SDB be it acutely or after a 90 day therapy, in comparison to CPAP. The most significant factor in the process of diagnosing sleep apnea is getting the indices of SDB normalized (Smith, Comella & Högl, 2008). When SDB gets optimally controlled, they provide better health results as compared to the one with residual SDB. This is more evident when it comes to those patients with heart complications and CSA, those diagnosed with SDB end up having improved cardiovascular results. Finally, the study will have demonstrated that CompSAS diminishes for about 30-60% of patients diagnosed with CPAP. When it comes to both the short durations and long durations in controlling SDB, ASV delivers better results than CPAP. References Aldrich, M. (1999). Sleep medicine. New York: Oxford University Press. Barnes, E. (2006). Diseases and human evolution. Albuquerque: University of New Mexico Press. Carney, P., Berry, R., & Geyer, J. (2005). Clinical sleep disorders. Philadelphia: Lippincott Williams & Wilkins. Epstein, L., & Mardon, S. (2007). The Harvard Medical School guide to a good nights sleep. New York: McGraw-Hill. Gay, P. Central sleep apnea. Guilleminault, C. (2005). Clinical neurophysiology of sleep disorders. Edinburgh: Elsevier. Kushida, C. (2007). Obstructive sleep apnea. New York, NY: Informa Healthcare. Montagna, P., & Chokroverty, S. (2011). Sleep disorders. Edinburgh: Elsevier. Randerath, W., Sanner, B., & Somers, V. (2006). Sleep apnea. Basel: Karger. Smith, H., Comella, C., & Högl, B. (2008). Sleep medicine. Cambridge, UK: Cambridge University Press. Read More