Clinical trial NCT03754270: Cervical Collar for Patients With Moderate Obstructive Sleep Apnea
Official title: Evaluation of Treatment Effect of Cervical Collar in Moderate Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Apnea/hypopnea index
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment.
timeFrame: 6+/- 2 weeks of treatment.
Secondary outcomes:
Other outcomes:
measure: Number of apneas
timeFrame: 6+/- 2 weeks of treatment.
measure: Number of hypopneas
timeFrame: 6+/- 2 weeks of treatment.
measure: Variation of body position during sleep
timeFrame: 6+/- 2 weeks of treatment.
measure: Mean level of saturation
timeFrame: 6+/- 2 weeks of treatment.
measure: Oxygen desaturation index (ODI)
timeFrame: 6+/- 2 weeks of treatment.
measure: Percentage of sleeping time with oxygen saturation <90%
timeFrame: 6+/- 2 weeks of treatment.
measure: Respiratory rate
timeFrame: 6+/- 2 weeks of treatment.
measure: Mean heart rate
timeFrame: 6+/- 2 weeks of treatment.
measure: Quality of life is recorded with 36-item Short Form Health Survey (SF36)
timeFrame: 6+/- 2 weeks of treatment.
measure: Quality of sleep is recorded with adapted questions from Basic Nordic Sleep Questionnaire (BNSQ)
timeFrame: 6+/- 2 weeks of treatment.
measure: Sleepiness is recorded with Epworth Sleepiness Scale (ESS)
timeFrame: 6+/- 2 weeks of treatment.
measure: Tolerability of treatment with CC
timeFrame: 6+/- 2 weeks of treatment.
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university
Study officials:
affiliation: Uppsala University
name: Florim Delijaj
role: PRINCIPAL_INVESTIGATOR
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