protocolSection identificationModule nctId: NCT06330116, orgStudyIdInfo id: 2023-05348-01, briefTitle: Different Forms of OMT as Methods for Reducing Snoring and Mild to Moderate Sleep Apnea, acronym: SNORT, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2025-03-28, completionDateStruct date: 2025-03-28, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Region Västerbotten, class: OTHER_GOV, collaborators name: Interreg, collaborators name: Umeå University, descriptionModule briefSummary: Objective the present project aims to assess the impact of 1) oral screen training, group training, and the use of neuromuscular electrical training (NMES) as orofacial myofunctional therapy (OMT) methods for reducing the apnea-hypopnea index (AHI) among adults with mild to moderate sleep apnea and 2) if these different training methods can reduce snoring and affect the level of sleepiness and quality of life. Study design The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase, and follow-up measurements.Methods 141 consecutive adult subjects, 71 men and 70 women referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sites, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the three different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Participants in Umeå will be randomized to either training with IQoro or serving as controls. Participants in Köge will be randomized to either training with Exciteosa, group training, or controls.The primary outcome is a change in AHI before and after three months of training with the different methods according to overnight ambulatory sleep apnea recordings.The secondary outcomes are change in snoring frequency, sound level dB (A) according to a questionnaire, the Basic Nordic Sleep Questionnaire (BNSQ), daytime sleepiness using the Epworth Sleepiness Scale (ESS), change in quality of life using the short form -36 (SF-36) and muscle strength in tongue before and after treatment., conditionsModule conditions: Sleep Apnea, Obstructive, conditions: Snoring, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 141 consecutive adult subjects, 71 men and 70 women, referred to hospital, due to symptoms of snoring and mild to moderate sleep apnea will be randomized, included, and examined at three different sights, Umeå(Sweden), Lund(Sweden) and Köge(Denmark) One hundred-five of them, 35 in each treatment group, will receive one of the 3 different forms of training and the final 36 persons serving as controls, age/AHI matched (18 in Köge resp Umeå). Patients in Umeå will be randomized to either training with IQoro or serving as controls. Patients in Köge will be randomized to either training with Exciteosa group training, or controls., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The study will use a prospective randomized open-blinded endpoint (PROBE) design with baseline measurements, intervention phase and follow-up measurements, and controls without intervention. The results are then analyzed and blinded to the evaluators., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 141, type: ESTIMATED, armsInterventionsModule interventions name: IQoro, interventions name: eXciteosa, interventions name: Grouptraining, outcomesModule primaryOutcomes measure: Apnea-hyponpnea index (AHI), secondaryOutcomes measure: Questionnaries, secondaryOutcomes measure: Snoring, secondaryOutcomes measure: Tounge strenght, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zealand University Hospital, city: Köge, state: Sjaelland, zip: 4600, country: Denmark, geoPoint lat: 55.45802, lon: 12.18214, locations facility: Skåne University Hospital, city: Lund, state: Skåne, zip: 22100, country: Sweden, geoPoint lat: 55.70584, lon: 13.19321, locations facility: Region Västerbotten, city: Umeå, state: Västerbotten, zip: 901 85, country: Sweden, geoPoint lat: 63.82842, lon: 20.25972, hasResults: False