Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluation of Treatment Effect of Cervical Collar in Moderate Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754270
• Other study ID #: CCMOSA-01
• Status: Completed
• Phase: N/A
• Start date: June 16, 2019
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Advice in lifestyle
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.

Device:
• Cervical collar
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.

Locations

Country	Name	City	State
Sweden	Uppsala university	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (9)

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. — View Citation

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. — View Citation

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;6 — View Citation

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. — View Citation

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. do — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of apneas	Apnea is defined as a respiratory arrest during sleep which means more than 90% decrease in respiratory airflow lasting more than 10 seconds with preserved respiratory movement in the thoracic or abdominal wall. This variable is recorded by Nocturnal Respiratory Registration (NRR).	6+/- 2 weeks of treatment.
Other	Number of hypopneas	Hypopnea is defined as partial respiratory disturbance during sleep which means a more than 50% decrease in nasal air pressure signal from baseline lasting more than 10. This variable is recorded by Nocturnal Respiratory Registration (NRR).	6+/- 2 weeks of treatment.
Other	Variation of body position during sleep	Sleeping in the supine position is increased risk factor that contribute to development of OSA. This variable is recorded by Nocturnal Respiratory Registration (NRR).	6+/- 2 weeks of treatment.
Other	Mean level of saturation	OSA cause decrease of oxygen saturation in blood. This variable is recorded by pulse oximeter. Normal pulse oximeter readings usually range from 95 to 100 percent.	6+/- 2 weeks of treatment.
Other	Oxygen desaturation index (ODI)	A number of desaturations more than 3% from baseline during sleep divided by number of sleeping hours.This variable is recorded by pulse oximeter.	6+/- 2 weeks of treatment.
Other	Percentage of sleeping time with oxygen saturation <90%	It is important för assessing the difference between treatment methods. This variable is recorded by pulse oximeter.	6+/- 2 weeks of treatment.
Other	Respiratory rate	It is important for assessing the difference between treatment methods. This variable is recorded by NRR.	6+/- 2 weeks of treatment.
Other	Mean heart rate	It is important for assessing the difference between treatment methods. This variable is recorded by NRR.	6+/- 2 weeks of treatment.
Other	Quality of life is recorded with 36-item Short Form Health Survey (SF36)	Short Form Health Survey (SF36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scoring is a two-step process. First, precoded numeric values are recorded per the scoring key given in Table 1. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Hence, scale scores represent the average for all items in the scale that the respondent answered.	6+/- 2 weeks of treatment.
Other	Quality of sleep is recorded with adapted questions from Basic Nordic Sleep Questionnaire (BNSQ)	Basic Nordic Sleep Questionnaire (BNSQ) consists of 27 items in 21 different questions and queries a wide range of sleep complaints, including difficulties initiating and maintaining sleep, subjective sleep quality, the use of medication to induce sleep, excessive daytime sleepiness, napping, snoring, and general sleep habits.Sleepiness scores range from 4 to 20 points, insomnia scores from 7 to 35, the higher scores indicating more problems with sleepiness or insomnia.	6+/- 2 weeks of treatment.
Other	Sleepiness is recorded with Epworth Sleepiness Scale (ESS)	Epworth Sleepiness Scale (ESS) measures a respondent's general level of daytime sleepiness, or their average sleep propensity in daily life.It is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.	6+/- 2 weeks of treatment.
Other	Tolerability of treatment with CC	It is important for assessing the patient's perception of treatment with CC. This variable is only recorded in experimental arm. There are three simple questions that respondent's should answer: "How do you experience treatment in general?" (range very good - very bad), "Do you want to continue with the treatment?" ( yes or no) and "Own comments about the treatment".	6+/- 2 weeks of treatment.
Primary	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.