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| ID | Type | Description | Link |
|---|---|---|---|
| Dnr 07-032M |
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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
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The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.
Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adjustable mandibular repositioning appliance |
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| 2 | Placebo Comparator | Placebo device in upper jaw |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular repositioning appliance, adjustable | Device | Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep apnea and sleep measured by polysomnography | Baseline and after 4 months | |
| Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing | Baseline and after 4 months | |
| Quality of life | Baseline and after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Headaches | Baseline and after 4 months | |
| Blood pressure | Baseline and after 4 months | |
| Vigilance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Marklund | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depts of Respiratory Medicine and Orthodontics, Umeå University | Umeå | SE-906 51 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15078734 | Background | Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004 Apr;125(4):1270-8. doi: 10.1378/chest.125.4.1270. | |
| 16437488 | Background | Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004435. doi: 10.1002/14651858.CD004435.pub3. |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D012913 | Snoring |
| D006970 | Disorders of Excessive Somnolence |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D017289 | Orthodontic Appliances, Functional |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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| Baseline and after 4 months |
| Markers of stress | Baseline and after 4 months |
| Markers of inflammation | Baseline and after 4 months |
| Markers of cardiovascular health and oxidative stress | Baseline and after 4 months |
| Side-effects from the treatment | After 4 months treatment |
| Predictors of effects on symptoms and sleep apneas | After 4 months treatment |
| 29929990 | Derived | Rietz H, Franklin KA, Carlberg B, Sahlin C, Marklund M. Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial. J Am Heart Assoc. 2018 Jun 21;7(13):e008642. doi: 10.1161/JAHA.118.008642. |
| 26030264 | Derived | Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. 2015 Aug;175(8):1278-85. doi: 10.1001/jamainternmed.2015.2051. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |