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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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