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Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03754270
Recruitment Status : Unknown
Verified November 2018 by Uppsala University.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Other: Advice in lifestyle Device: Cervical collar Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Treatment Effect of Cervical Collar in Moderate Obstructive Sleep Apnea
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Lifestyle advice
Patients receive instructions and advice on lifestyle according to current clinical practice.
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.

Experimental: Lifestyle advice and 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.
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.




Primary Outcome Measures :
  1. Changes in Apnea Hypopnea Index (AHI) measured at baseline and after 6+/- 2 weeks of treatment. [ Time Frame: 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.


Other Outcome Measures:
  1. Number of apneas [ Time Frame: 6+/- 2 weeks of treatment. ]
    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).

  2. Number of hypopneas [ Time Frame: 6+/- 2 weeks of treatment. ]
    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).

  3. Variation of body position during sleep [ Time Frame: 6+/- 2 weeks of treatment. ]
    Sleeping in the supine position is increased risk factor that contribute to development of OSA. This variable is recorded by Nocturnal Respiratory Registration (NRR).

  4. Mean level of saturation [ Time Frame: 6+/- 2 weeks of treatment. ]
    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.

  5. Oxygen desaturation index (ODI) [ Time Frame: 6+/- 2 weeks of treatment. ]
    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. Percentage of sleeping time with oxygen saturation <90% [ Time Frame: 6+/- 2 weeks of treatment. ]
    It is important för assessing the difference between treatment methods. This variable is recorded by pulse oximeter.

  7. Respiratory rate [ Time Frame: 6+/- 2 weeks of treatment. ]
    It is important for assessing the difference between treatment methods. This variable is recorded by NRR.

  8. Mean heart rate [ Time Frame: 6+/- 2 weeks of treatment. ]
    It is important for assessing the difference between treatment methods. This variable is recorded by NRR.

  9. Quality of life is recorded with 36-item Short Form Health Survey (SF36) [ Time Frame: 6+/- 2 weeks of treatment. ]
    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.

  10. Quality of sleep is recorded with adapted questions from Basic Nordic Sleep Questionnaire (BNSQ) [ Time Frame: 6+/- 2 weeks of treatment. ]
    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.

  11. Sleepiness is recorded with Epworth Sleepiness Scale (ESS) [ Time Frame: 6+/- 2 weeks of treatment. ]
    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.

  12. Tolerability of treatment with CC [ Time Frame: 6+/- 2 weeks of treatment. ]

    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".




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754270


Contacts
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Contact: Florim Delijaj +46702237991 florim.delijaj@dll.se

Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Florim Delijaj Uppsala University
Publications of Results:

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03754270    
Other Study ID Numbers: CCMOSA-01
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Apnea/hypopnea index
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases