Cervical Collar for Patients With Moderate Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Advice in lifestyle; Cervical collar
Intervention type(s): Other; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Apnea/hypopnea index