Lifestyle Intervention for OSA in Adults

January 9, 2021 updated by: Almudena Carneiro Barrera, Universidad de Granada

Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: A Randomized Controlled Trial

Obstructive sleep apnoea (OSA) is characterized by the presence in the polysomnogram test of more than five apnoea-hypopnoea episodes per hour of sleep (apnoea-hypopnoea index, AHI > 5), each episode lasting more than 10 seconds and being accompanied by oxygen desaturation or arousal. The prevalence of this syndrome is worryingly high (9% to 38%), affecting more men than women. OSA has an important negative impact on physical/psychological health and on these patient's quality of life. The gold-standard treatment for OSA is the continuous positive airway pressure (CPAP). However, CPAP compliance is really low, this device requiring a continuous chronic use in order to improve OSA and to avoid the relapse. Furthermore, it does not address OSA risk factors such as obesity and unhealthy lifestyle habits. Consequently, non-surgical and non-pharmacological interventions such as weight loss and lifestyle interventions are necessary and recommended by the American Academy of Sleep Medicine (AASM). The objective of this project, therefore, is the development and evaluation of a cognitive-behavioural treatment program for patients with moderate-severe OSA. The treatment will pursued weight loss through hypocaloric diet and moderate exercise, smoking and alcohol avoidance, and sleep hygiene. The efficacy of this treatment will be assessed in comparison with CPAP, in a short and medium term. This intervention could be considered a good alternative/combined management to the usual treatment of OSA (CPAP) once its efficacy to reduce and even cure OSA symptoms is demonstrated, especially if it is still effective in the long-term.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

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 Locations

  • Spain
      • Granada, Spain, 18011
        • University of Granada

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Previous clinical diagnosis of moderate/severe OSA (AHI > 15) by a healthcare professional.
  • Male patients aged between 18-65 years.
  • Body mass index > 25 kg/m2.
  • Use of CPAP
  • Motivation to participate in the study.
  • Signed informed consent form.

Exclusion Criteria:

  • Sleep disorder other than OSA
  • Clinically significant psychiatric, neurological, or medical disorders other than OSA
  • Use of prescription drugs or clinically significant drugs affecting sleep

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention Group (LIG)
Participants from this group will receive a cognitive-behavioral intervention addressing weight loss and lifestyle habits such as hypocaloric diet, moderate exercise, smoking and alcohol avoidance, and sleep hygiene. This behavioral intervention will be combined with the usual treatment for OSA, i.e. CPAP.
Behavioral: Lifestyle Intervention
Cognitive-behavioural intervention for weight loss and lifestyle change
No Intervention: Control group
Participants from the control group will not receive any type of intervention apart from the usual care (CPAP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.
Time Frame: Post-intervention (2 months)
Change in apnoea (airflow reduction greater than or equal to 90%) and hypopnoea (airflow reduction greater than or equal to 30%) episodes per hour of sleep, from baseline to post-intervention.
Post-intervention (2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oxygen desaturation index (ODI) from baseline to post-intervention.
Time Frame: Post-intervention (2 months)
Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.
Post-intervention (2 months)
Change in oxygen saturation (SaO2) mean from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the average of oxygen saturation from baseline to post-intervention
Post-intervention (2 months)
Change in oxygen saturation (SaO2) nadir from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Minimum oxygen saturation from baseline to post-intervention
Post-intervention (2 months)
Change in sleep efficiency from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the total sleep time/total time in bed from baseline to post-intervention
Post-intervention (2 months)
Change in light sleep (N1 and N2 stages) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention
Post-intervention (2 months)
Change in deep sleep (N3 stage) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention
Post-intervention (2 months)
Change in rapid eye movement (REM) sleep from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the percentage of REM sleep from baseline to post-intervention
Post-intervention (2 months)
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Time Frame: Post-intervention (2 months)
Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.
Post-intervention (2 months)
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Time Frame: Post-intervention (2 months)
Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.
Post-intervention (2 months)
Change in excessive daytime sleepiness (EDS) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in the difficulty in maintaining a desired level of wakefulness, measured by the Epworth sleepiness scale (ESS) from baseline to post-intervention. ESS is a 4-point scale (0 = no chance of dozing, 1 = slight chance of dozing, 2 = moderate chance of dozing, 3 = high chance of dozing) that measures the usual chances of dozing off or falling asleep while engaged in eight different activities. An ESS total score from 0 to 9 is considered to be normal while an ESS total score > 9 indicates high daytime sleepiness.
Post-intervention (2 months)
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.
Time Frame: Post-intervention (2 months)
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention. This scale includes a total of 19 self-rated items combined to form seven component scores i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction), each of which has a range of 0-3 points. The sum of these seven PSQI component scores is considered to obtain a global PSQI score (ranging from 0-21), with higher scores indicating poorer sleep quality.
Post-intervention (2 months)
Change in Wake After Sleep Onset (WASO) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention
Post-intervention (2 months)
Change in body weight (kg) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in body weight (kg) from baseline to post-intervention
Post-intervention (2 months)
Change in fat mass (kg) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in fat mass (kg) from baseline to post-intervention
Post-intervention (2 months)
Change in mean blood pressure (mm HG) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in mean blood pressure (mm HG) from baseline to post-intervention
Post-intervention (2 months)
Change in plasma glucose (mg/dL) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in plasma glucose (mg/dL) from baseline to post-intervention
Post-intervention (2 months)
Change in total cholesterol (mg/dL) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in total cholesterol (mg/dL) from baseline to post-intervention
Post-intervention (2 months)
Change in total triglycerides (mg/dL) from baseline to post-intervention
Time Frame: Post-intervention (2 months)
Change in total triglycerides (mg/dL) from baseline to post-intervention
Post-intervention (2 months)

Collaborators and Investigators

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

Sponsor

Universidad de Granada

Investigators

  • Study Director: Jonatan R. Ruiz, PhD, Universidad de Granada
  • Principal Investigator: Almudena Carneiro-Barrera, MD, Universidad de Granada

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)

April 1, 2019

Primary Completion (Actual)

October 13, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 9, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INTERAPNEA-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data (IPD) that underlie results in a publication

IPD Sharing Time Frame

After publication

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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