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Obstructive Sleep ApneaNCT03754270

Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

A study testing Advice in lifestyle and Cervical collar in people with Obstructive Sleep Apnea, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Advice in lifestyle and Cervical collar
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSweden
Study dates
16 Jun 2019to 30 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate obstructive sleep apnea (AHI 15-30)
  • BMI <35
  • Age 18-75
  • Signed Informed Consent

Who cannot join

  • 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
Show all 9Show fewer
  • 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 locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala university

    Uppsala, 751 22

Other trials in Sweden

About this study

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

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:

  1. 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).
Read the 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.

Being tested
Advice in lifestyle, Cervical collar
Keywords
Apnea/hypopnea index
Medical subject headings
Sleep Apnea, Obstructive, Apnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advice in lifestyleOther

    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.

  • Cervical collarDevice

    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.

Study groups in NCT03754270
Study groupRoleWhat they receive
Lifestyle adviceActive comparatorPatients receive instructions and advice on lifestyle according to current clinical practice.
Receives: Other: Advice in lifestyle
Lifestyle advice and cervical collarExperimentalPatients receive the same instructions and advice as in Arm "lifestyle advice" and also get a CC and instructions on how to sleep with it.
Receives: Device: Cervical collar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6+/- 2 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2018
  2. Study start16 Jun 2019
  3. Primary completion30 Jan 2023
  4. Study completion30 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03754270
Sponsor's protocol ID
CCMOSA-01
Status last verified
May 2023
First submitted
17 Oct 2018
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: It is not yet known if there will be a plan to make IPD available.

Publications

  • Wang X, Ouyang Y, Wang Z, Zhao G, Liu L, Bi Y. Obstructive sleep apnea and risk of cardiovascular disease and all-cause mortality: a meta-analysis of prospective cohort studies. Int J Cardiol. 2013 Nov 5;169(3):207-14. doi: 10.1016/j.ijcard.2013.08.088. Epub 2013 Sep 8.

    PubMed 24161531

  • Lindberg E, Carter N, Gislason T, Janson C. Role of snoring and daytime sleepiness in occupational accidents. Am J Respir Crit Care Med. 2001 Dec 1;164(11):2031-5. doi: 10.1164/ajrccm.164.11.2102028.

    PubMed 11739131

  • Valham F, Stegmayr B, Eriksson M, Hagg E, Lindberg E, Franklin KA. Snoring and witnessed sleep apnea is related to diabetes mellitus in women. Sleep Med. 2009 Jan;10(1):112-7. doi: 10.1016/j.sleep.2007.11.005. Epub 2008 Jan 22.

    PubMed 18207451

  • Bloom JW, Kaltenborn WT, Quan SF. Risk factors in a general population for snoring. Importance of cigarette smoking and obesity. Chest. 1988 Apr;93(4):678-83. doi: 10.1378/chest.93.4.678.

    PubMed 3258226

  • Farronato G, Storti E, Cuzzocrea ML, Lucchese A, Cossellu G, Assandri F, Biagi R. Three-dimensional changes of the upper airway in patients with obstructive sleep apnea syndrome after a non-adjustable oral appliance treatment. Minerva Stomatol. 2013 Apr;62(4):107-16. English, Italian.

    PubMed 23588211

  • Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.

    PubMed 26094920

  • Rose EC, Barthlen GM, Staats R, Jonas IE. Therapeutic efficacy of an oral appliance in the treatment of obstructive sleep apnea: a 2-year follow-up. Am J Orthod Dentofacial Orthop. 2002 Mar;121(3):273-9. doi: 10.1067/mod.2002.121006.

    PubMed 11941341

  • Richard W, Venker J, den Herder C, Kox D, van den Berg B, Laman M, van Tinteren H, de Vries N. Acceptance and long-term compliance of nCPAP in obstructive sleep apnea. Eur Arch Otorhinolaryngol. 2007 Sep;264(9):1081-6. doi: 10.1007/s00405-007-0311-3. Epub 2007 Apr 19.

    PubMed 17443336

  • Esclamado RM, Glenn MG, McCulloch TM, Cummings CW. Perioperative complications and risk factors in the surgical treatment of obstructive sleep apnea syndrome. Laryngoscope. 1989 Nov;99(11):1125-9. doi: 10.1288/00005537-198911000-00004.

    PubMed 2530406

Questions about this trial

What is this clinical trial studying?

A study testing Advice in lifestyle and Cervical collar in people with Obstructive Sleep Apnea, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment. (time frame: 6+/- 2 weeks of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03754270, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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Clinical Trial NCT03754270 | AzTrials