Cervical Collar for Patients With Moderate Obstructive Sleep Apnea

May 9, 2023 updated by: Uppsala University

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:

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 22
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6+/- 2 weeks of treatment.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6+/- 2 weeks of treatment.
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).
6+/- 2 weeks of treatment.
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).
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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.
6+/- 2 weeks of treatment.
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".
6+/- 2 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Florim Delijaj, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2019

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

January 30, 2023

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCMOSA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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