Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

Uppsala University

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Cervical collar; Other: Advice in lifestyle

Study type: Interventional

Funder types: Other

Identifiers

NCT03754270

CCMOSA-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Lifestyle advice

Active Comparator group

Description:

Patients receive instructions and advice on lifestyle according to current clinical practice.

Treatment:

Other: Advice in lifestyle

Lifestyle advice and cervical collar

Experimental group

Description:

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.

Treatment:

Device: Cervical collar