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Obstructive Sleep ApneaNCT03851653

Lifestyle Intervention for OSA in Adults

A study testing Lifestyle Intervention in people with Obstructive Sleep Apnea, run by Universidad de Granada at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years, men only
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Lifestyle Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteSpain
Study dates
1 Apr 2019to 30 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of Granada

    Granada, 18011

Other trials in Spain

About this study

Official title: 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.

Being tested
Lifestyle Intervention
Keywords
obstructive sleep apnea, weight loss, lifestyle intervention, continuous positive airway pressure, OSA, CPAP
Medical subject headings
Sleep Apnea, Obstructive, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle InterventionBehavioural

    Cognitive-behavioural intervention for weight loss and lifestyle change

Study groups in NCT03851653
Study groupRoleWhat they receive
Lifestyle Intervention Group (LIG)ExperimentalParticipants 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.
Receives: Behavioral: Lifestyle Intervention
Control groupNo interventionParticipants from the control group will not receive any type of intervention apart from the usual care (CPAP).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention.

    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.

    Measured: Post-intervention (2 months)

Secondary outcomes (18)

  1. Change in oxygen desaturation index (ODI) from baseline to post-intervention.

    Change in the number of oxygen desaturations greater than or equal to 4%/h from baseline to post-intervention.

    Measured: Post-intervention (2 months)

  2. Change in oxygen saturation (SaO2) mean from baseline to post-intervention

    Change in the average of oxygen saturation from baseline to post-intervention

    Measured: Post-intervention (2 months)

  3. Change in oxygen saturation (SaO2) nadir from baseline to post-intervention

    Minimum oxygen saturation from baseline to post-intervention

    Measured: Post-intervention (2 months)

  4. Change in sleep efficiency from baseline to post-intervention

    Change in the total sleep time/total time in bed from baseline to post-intervention

    Measured: Post-intervention (2 months)

  5. Change in light sleep (N1 and N2 stages) from baseline to post-intervention

    Change in the percentage of light sleep (N1 and N2 stages) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  6. Change in deep sleep (N3 stage) from baseline to post-intervention

    Change in the percentage of deep sleep (N3 stage) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  7. Change in rapid eye movement (REM) sleep from baseline to post-intervention

    Change in the percentage of REM sleep from baseline to post-intervention

    Measured: Post-intervention (2 months)

  8. Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.

    Change in apnoea-hypopnoea index (AHI) in REM sleep from baseline to post-intervention.

    Measured: Post-intervention (2 months)

  9. Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.

    Change in apnoea-hypopnoea index (AHI) in NREM sleep from baseline to post-intervention.

    Measured: Post-intervention (2 months)

  10. Change in excessive daytime sleepiness (EDS) from baseline to post-intervention

    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.

    Measured: Post-intervention (2 months)

  11. Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to post-intervention.

    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.

    Measured: Post-intervention (2 months)

  12. Change in Wake After Sleep Onset (WASO) from baseline to post-intervention

    Change in Wake After Sleep Onset (WASO; minutes) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  13. Change in body weight (kg) from baseline to post-intervention

    Change in body weight (kg) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  14. Change in fat mass (kg) from baseline to post-intervention

    Change in fat mass (kg) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  15. Change in mean blood pressure (mm HG) from baseline to post-intervention

    Change in mean blood pressure (mm HG) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  16. Change in plasma glucose (mg/dL) from baseline to post-intervention

    Change in plasma glucose (mg/dL) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  17. Change in total cholesterol (mg/dL) from baseline to post-intervention

    Change in total cholesterol (mg/dL) from baseline to post-intervention

    Measured: Post-intervention (2 months)

  18. Change in total triglycerides (mg/dL) from baseline to post-intervention

    Change in total triglycerides (mg/dL) from baseline to post-intervention

    Measured: Post-intervention (2 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start1 Apr 2019
  3. Primary completion13 Oct 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851653
Sponsor's protocol ID
INTERAPNEA-2019
Status last verified
Jan 2021
First submitted
20 Feb 2019
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) that underlie results in a publication

Publications

  • Carneiro-Barrera A, Diaz-Roman A, Guillen-Riquelme A, Buela-Casal G. Weight loss and lifestyle interventions for obstructive sleep apnoea in adults: Systematic review and meta-analysis. Obes Rev. 2019 May;20(5):750-762. doi: 10.1111/obr.12824. Epub 2019 Jan 4.

    PubMed 30609450

  • Sanchez AI, Martinez P, Miro E, Bardwell WA, Buela-Casal G. CPAP and behavioral therapies in patients with obstructive sleep apnea: effects on daytime sleepiness, mood, and cognitive function. Sleep Med Rev. 2009 Jun;13(3):223-33. doi: 10.1016/j.smrv.2008.07.002. Epub 2009 Feb 7.

    PubMed 19201228

  • Aiello KD, Caughey WG, Nelluri B, Sharma A, Mookadam F, Mookadam M. Effect of exercise training on sleep apnea: A systematic review and meta-analysis. Respir Med. 2016 Jul;116:85-92. doi: 10.1016/j.rmed.2016.05.015. Epub 2016 May 21.

    PubMed 27296826

  • Iftikhar IH, Bittencourt L, Youngstedt SD, Ayas N, Cistulli P, Schwab R, Durkin MW, Magalang UJ. Comparative efficacy of CPAP, MADs, exercise-training, and dietary weight loss for sleep apnea: a network meta-analysis. Sleep Med. 2017 Feb;30:7-14. doi: 10.1016/j.sleep.2016.06.001. Epub 2016 Jun 28.

    PubMed 28215266

  • Jurado-Gamez B, Guglielmi O, Gude F, Buela-Casal G. Effects of continuous positive airway pressure treatment on cognitive functions in patients with severe obstructive sleep apnoea. Neurologia. 2016 Jun;31(5):311-8. doi: 10.1016/j.nrl.2015.03.002. Epub 2015 May 11. English, Spanish.

    PubMed 25976943

  • Carneiro-Barrera A, Amaro-Gahete FJ, Diaz-Roman A, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Ruiz JR, Buela-Casal G. Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnoea in Adults: Rationale, Design and Methodology of the INTERAPNEA Study. Nutrients. 2019 Sep 15;11(9):2227. doi: 10.3390/nu11092227.

    PubMed 31540168

  • Herrera-Quintana L, Vazquez-Lorente H, Ruiz JR, Amaro-Gahete FJ, Carneiro-Barrera A. Impact of an interdisciplinary weight loss and lifestyle intervention on testosterone and scores for sexual activity on the FOSQ in men with obesity and obstructive sleep apnea: secondary analyses of data from the INTERAPNEA randomized trial. Maturitas. 2026 Aug;211:109045. doi: 10.1016/j.maturitas.2026.109045. Epub 2026 Jul 10.

    PubMed 42456328

  • Vazquez-Lorente H, Herrera-Quintana L, Ruiz JR, Amaro-Gahete FJ, Carneiro-Barrera A. Impact of weight loss and lifestyle intervention on vitamin D in men with obstructive sleep apnea: The INTERAPNEA trial. Sleep Med. 2025 Apr;128:37-45. doi: 10.1016/j.sleep.2025.01.011. Epub 2025 Jan 21.

    PubMed 40023509

  • Carneiro-Barrera A, Amaro-Gahete FJ, Lucas JF, Saez-Roca G, Martin-Carrasco C, Lavie CJ, Ruiz JR. Weight loss and lifestyle intervention for cardiorespiratory fitness in obstructive sleep apnea: The INTERAPNEA trial. Psychol Sport Exerc. 2024 May;72:102614. doi: 10.1016/j.psychsport.2024.102614. Epub 2024 Feb 17.

    PubMed 38369267

  • Carneiro-Barrera A, Amaro-Gahete FJ, Saez-Roca G, Martin-Carrasco C, Palmeira AL, Ruiz JR. Interdisciplinary Weight Loss and Lifestyle Intervention for Daily Functioning and Psychiatric Symptoms in Obstructive Sleep Apnea: The INTERAPNEA Randomized Clinical Trial. J Clin Psychiatry. 2023 Jun 12;84(4):22m14502. doi: 10.4088/JCP.22m14502.

    PubMed 37339363

  • Carneiro-Barrera A, Amaro-Gahete FJ, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Tinahones FJ, Ruiz JR. Effect of a Weight Loss and Lifestyle Intervention on Dietary Behavior in Men with Obstructive Sleep Apnea: The INTERAPNEA Trial. Nutrients. 2022 Jun 30;14(13):2731. doi: 10.3390/nu14132731.

    PubMed 35807913

  • Carneiro-Barrera A, Amaro-Gahete FJ, Guillen-Riquelme A, Jurado-Fasoli L, Saez-Roca G, Martin-Carrasco C, Buela-Casal G, Ruiz JR. Effect of an Interdisciplinary Weight Loss and Lifestyle Intervention on Obstructive Sleep Apnea Severity: The INTERAPNEA Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e228212. doi: 10.1001/jamanetworkopen.2022.8212.

    PubMed 35452108

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Intervention in people with Obstructive Sleep Apnea, run by Universidad de Granada at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in apnoea-hypopnoea index (AHI) from baseline to post-intervention. (time frame: Post-intervention (2 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851653, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.

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