Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

Study Overview
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Brief Summary
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This study evaluates treatment effect of Cervical Collar (CC) in moderate obstructive sleep apnea.The investigators believe that stabilization of the neck by using a CC during sleep helps sustain airway patency. This would mean preventing collapse of airways during sleep. The study is a randomized, open, parallel-group intervention study. The two treatment groups are: A. Patients with moderate OSA are treated with lifestyle advice (n = 50) B. Patients with moderate OSA are treated with CC and lifestyle advice (n = 50).

Detailed Description
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Moderate and severe obstructive sleep apnea (OSA) is strongly associated with cardiovascular diseases, diabetes and also with occupational and traffic accidents due to fatigue and daytime sleepiness. Treatment of moderate OSA is usually by a mandibular advancement device (MAD) and in sometimes even Continuous Positive Airway Pressure (CPAP). MAD and CPAP treatment effectiveness is impeded by limited compliance with long term treatment. Knowledge about mechanical barriers in upper respiratory tract has triggered interest in finding a new treatment method that may prevent collapse of airways during sleep. The investigators believe that stabilization of the neck by using a cervical collar (CC) during sleep helps sustain airway patency. This would mean improved oxygen saturation in the blood and a reduction of daytime fatigue in patients with OSA.

Official Title
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Evaluation of Treatment Effect of Cervical Collar in Moderate Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: Advice in lifestyle
* Device: Cervical collar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate obstructive sleep apnea (AHI 15-30) BMI <35 Age 18-75 Signed Informed Consent Exclusion Criteria: Ongoing or planned pregnancy during intervention Whiplash injury or other neck pain Rheumatic diseases Dementia Active alcohol or drug abuse <2 back in time Treatment with sleeping pills or other sedatives Cannot wear CC for any reason Pregnant or lactating women Not expected to be able to comply with nighttime breathing registration/treatment due to medical and/or psychological conditions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, open, parallel-group intervention study. The two treatment groups are: A.Patients with moderate OSA are treated with lifestyle advice (n = 50) B. Patients with moderate OSA are treated with CC and lifestyle advice (n = 50). Life style advice is quite subjective and it means that the patients are encouraged to stop smoking, to avoid alcohol, to lose weight, to be more physically active and to avoid sleeping on supine position.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lifestyle advice<br>Patients receive instructions and advice on lifestyle according to current clinical practice. | Other: Advice in lifestyle<br>* Patients with moderate OSA according to a baseline nocturnal respiratory registration (NRR). Patients receive instructions and advice on lifestyle according to current clinical practice. Life style advice is quite subjective and it means that the patients are encouraged to stop smoking, to avoid alcohol, to lose weight, to be more physically active and to avoid sleeping on supine position.Patients fill in questionnaire 1 that includes questions about nocturnal respiratory disturbances, daytime sleepiness, insomnia, use of tobacco and alcohol, comorbidity and medication. After 6+/-2 weeks of treatment, patients fill in Questionnaire 2 which contains the same questions as Questionnaire 1 and also questions about any side effects, evaluation of treatment. In conjunction with visit 2 another NRR will be performed.<br>|
| Experimental: Lifestyle advice and cervical collar<br>Patients receive the same instructions and advice as in Arm lifestyle advice and also get a CC and instructions on how to sleep with it. | Device: Cervical collar<br>* Patients with moderate OSA according to a baseline nocturnal respiratory registration (NRR). Patients receive the same instructions and advice as in Arm lifestyle advice and also get a CC and instructions on how to sleep with it. CC is marketed for indications of various diseases such as traumatic cervical injury, cervical disc herniation and other neck problems and allows adjustment of the elevation level to achieve sufficient effect, i.e., extending the neck.Patients fill in questionnaire 1 that includes questions about nocturnal respiratory disturbances, daytime sleepiness, insomnia, use of tobacco and alcohol, comorbidity and medication. After 6+/-2 weeks of treatment, patients fill in Questionnaire 2 which contains the same questions as Questionnaire 1 and also questions about any side effects, evaluation of treatment. In conjunction with visit 2 another NRR will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment. | The definition of AHI is the sum of apneas and hypopneas divided by registration/sleep time. Se below description of Apnea and Hypopnea. According to the international classification of sleep disorders, mild Obstructive Sleep Apnae (OSA) is defined as AHI between 5-15, moderate as AHI between 15-30 and severe sleep apnea as AHI > 30. | 6+/- 2 weeks of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apnea/hypopnea index