Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699463
• Other study ID #: MA200216
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 2019

Study information

• Verified date: January 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment. Although some evidence exists of the benefits of treating mild OSA when scoring as per AASM 2007 criteria, more evidence is needed. The investigators wish to add to this pool of knowledge and also increase the inclusion criteria to include the AASM 2012 definition of mild OSA. By including the 2012 AASM definition of mild OSA, the investigators will add novel information to the field by assessing the benefits of treatment in both sub-groups of mild OSA.

Description:

Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).

At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.

After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Study Inclusion Criteria

• Aged = 18 and = 80

• Ability and willingness to provide written informed consent

• AHI = 15 as per AASM 2007 scoring criteria

• Ability to tolerate a CPAP one hour long run in test

Exclusion Criteria:

• The presence of unstable cardiac disease

• Inability to give fully informed consent

• Supplemental oxygen

• Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome

• ESS = 15, or concerns about sleepy driving from physician/ sleep lab staff

• BMI = 40

Related Conditions & MeSH terms

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

Intervention

Device:
• Continous Positive Airway Pressure
CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA

Other:
• Control Group
Standard sleep hygiene counseling as per published guidelines

Locations

Country	Name	City	State
United Kingdom	Blackpool Teaching Hospital	Blackpool
United Kingdom	Papworth Hospital	Cambridge
United Kingdom	Tayside Health Board, Ninewells Hospital	Dundee
United Kingdom	Aintree University Hospital	Liverpool
United Kingdom	Guys & St Thomas Hospital	London
United Kingdom	Royal Brompton Hospital, Imperial College London	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne	Newcastle
United Kingdom	Oxford Centre for Respiratory Medicine	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Lister Hospital	Stevenage
United Kingdom	Taunton and Somerset Hospital	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire	The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group.; In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible.	3 months