Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Advice in lifestyle; Device: Cervical collar

• Registration Number: NCT03754270
• Lead Sponsor: Uppsala University

Brief 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.

Study Timeline

• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Study Start: 2019-06-16
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle advice	Advice in lifestyle	Patients receive instructions and advice on lifestyle according to current clinical practice.
Lifestyle advice and cervical collar	Cervical collar	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.

Primary Outcome Measures

Name	Time	Method
Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment.	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.

Trial Locations

Locations (1)

Uppsala university; 🇸🇪 Uppsala, Sweden