Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

NCT03754270 | Completed DMC

• 1 other identifier: CCMOSA-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea

Keywords

Apnea/hypopnea index

Outcome Measures

Primary Outcomes (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.

  6+/- 2 weeks of treatment.

Other Outcomes (12)

• Number of apneas

  6+/- 2 weeks of treatment.

• Number of hypopneas

  6+/- 2 weeks of treatment.

• Variation of body position during sleep

  6+/- 2 weeks of treatment.

Study Arms (2)

Lifestyle advice

ACTIVE COMPARATOR

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

Other: Advice in lifestyle

Lifestyle advice and cervical collar

EXPERIMENTAL

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.

Device: Cervical collar

Interventions

Advice in lifestyle OTHER

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.

Lifestyle advice

Cervical collar DEVICE

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.

Lifestyle advice and cervical collar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala university

Uppsala, 751 22, Sweden

Location

Related Publications (9)

• 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.

  PMID: 24161531 RESULT

• 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.

  PMID: 11739131 RESULT

• 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.

  PMID: 18207451 RESULT

• 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.

  PMID: 3258226 RESULT

• 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.

  PMID: 23588211 RESULT

• 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.

  PMID: 26094920 RESULT

• 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.

  PMID: 11941341 RESULT

• 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.

  PMID: 17443336 RESULT

• 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.

  PMID: 2530406 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea

Interventions

Counseling

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Florim Delijaj

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 27, 2018
• Study Start: June 16, 2019
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

SE (1)