Obstructive Sleep ApneaINTERAPNEA-WNCT06370806
Lifestyle Intervention for Obstructive Sleep Apnea in Women
A study testing Weight loss and lifestyle intervention in people with Obstructive Sleep Apnea, run by Universidad de Granada.
Trial summary
Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Weight loss and lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Dec 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous clinical diagnosis of moderate/severe OSA (AHI > 15)
- Female 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
No sites are listed yet.
About this study
Official title: Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial
Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Weight loss and lifestyle intervention
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss and lifestyle interventionBehavioural
Interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants from the usual care group will not receive any type of intervention apart from the usual care (CPAP). |
| Lifestyle Intervention | Experimental | Participants from this group will receive a interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP) Receives: Behavioral: Weight loss and lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnoea-hypopnoea index (AHI)
Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Secondary outcomes (20)
Oxygen desaturation index (ODI)
Change in the number of oxygen desaturations greater than or equal to 4%/h measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Oxygen saturation (SaO2) mean
Change in the average of oxygen saturation measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Oxygen saturation (SaO2) nadir
Minimum oxygen saturation measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Sleep efficiency
Change in the total sleep time/total time in bed measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Light sleep (N1 and N2 stages)
Change in the percentage of light sleep (N1 and N2 stages) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Deep sleep (N3 stage)
Change in the percentage of deep sleep (N3 stage) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Rapid eye movement (REM) sleep
Change in the percentage of REM sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Excessive daytime sleepiness (EDS)
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)
Sleep Quality
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)
Wake After Sleep Onset (WASO)
Change in Wake After Sleep Onset (WASO; minutes) measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Fat mass (kg)
Change in fat mass (kg) measured by a whole-body densitometry using dual-energy X-ray absorptiometry (DEXA), from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Visceral adipose tisue (g)
Change in visceral adipose tisue (g) measured by a whole-body densitometry using dual-energy X-ray absorptiometry (DEXA), from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Body weight (kg)
Change in body weight (kg) measured by a scale from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Neck circumference (cm)
Change in neck circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Chest circumference (cm)
Change in chest circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Waist circumference (cm)
Change in waist circumference (cm) measured by a tape measure from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Mean blood pressure (mm HG)
Change in mean blood pressure (mm HG) measured by a blood pressure cuff from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Plasma glucose (mg/dL)
Change in plasma glucose (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Change in total cholesterol (mg/dL) from baseline to post-intervention
Change in total cholesterol (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months)
Measured: Post-intervention (2 months)
Change in total triglycerides (mg/dL) from baseline to post-intervention
Change in total triglycerides (mg/dL) measured by a blood test from baseline (week 0) to post-intervention (2 months)
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.
- First posted17 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación BBVA, Universidad Loyola Andalucia
- Responsible party
- Principal investigator, Almudena Carneiro Barrera, Universidad Loyola Andalucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370806
- Sponsor's protocol ID
- INTERAPNEA-Women
- Acronym
- INTERAPNEA-W
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 17 Apr 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary Weight Loss and Lifestyle Intervention for Obstructive Sleep Apnea in Women: The INTERAPNEA-Women Clinical Trial
- ClinicalTrials.gov ID
- NCT06370806
- Acronym / sponsor ID
- INTERAPNEA-W / INTERAPNEA-Women
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Fundación BBVA, Universidad Loyola Andalucia
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants from the usual care group will not receive any type of intervention apart from the usual care (CPAP). |
| Lifestyle Intervention | Experimental | Behavioral: Weight loss and lifestyle interventionParticipants from this group will receive a interdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previous clinical diagnosis of moderate/severe OSA (AHI > 15)
- Female patients aged between 18-65 years.
- Body mass index > 25 kg/m2.
- Use of CPAP.
- Motivation to participate in the study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss and lifestyle interventionInterdisciplinary intervention addressing weight loss and lifestyle change including nutritional behavior change, aerobic exercise, sleep hygiene, and alcohol and tobacco cessation combined with usual care (i.e., CPAP) | Behavioural | Lifestyle Intervention |
Primary outcome
Apnoea-hypopnoea index (AHI)
Time frame: Post-intervention (2 months)
Change in apnea (airflow reduction greater than or equal to 90%) and hypopnea (airflow reduction greater than or equal to 30%) episodes per hour of sleep measured by a respiratory polygraphy, from baseline (week 0) to post-intervention (2 months)
20 secondary outcomes
Oxygen desaturation index (ODI)
Time frame: Post-intervention (2 months)
Oxygen saturation (SaO2) mean
Time frame: Post-intervention (2 months)
Oxygen saturation (SaO2) nadir
Time frame: Post-intervention (2 months)
Sleep efficiency
Time frame: Post-intervention (2 months)
Light sleep (N1 and N2 stages)
Time frame: Post-intervention (2 months)
Deep sleep (N3 stage)
Time frame: Post-intervention (2 months)
Rapid eye movement (REM) sleep
Time frame: Post-intervention (2 months)
Excessive daytime sleepiness (EDS)
Time frame: Post-intervention (2 months)
Sleep Quality
Time frame: Post-intervention (2 months)
Wake After Sleep Onset (WASO)
Time frame: Post-intervention (2 months)
Fat mass (kg)
Time frame: Post-intervention (2 months)
Visceral adipose tisue (g)
Time frame: Post-intervention (2 months)
Body weight (kg)
Time frame: Post-intervention (2 months)
Neck circumference (cm)
Time frame: Post-intervention (2 months)
Chest circumference (cm)
Time frame: Post-intervention (2 months)
Waist circumference (cm)
Time frame: Post-intervention (2 months)
Mean blood pressure (mm HG)
Time frame: Post-intervention (2 months)
Plasma glucose (mg/dL)
Time frame: Post-intervention (2 months)
Change in total cholesterol (mg/dL) from baseline to post-intervention
Time frame: Post-intervention (2 months)
Change in total triglycerides (mg/dL) from baseline to post-intervention
Time frame: Post-intervention (2 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss and lifestyle intervention in people with Obstructive Sleep Apnea, run by Universidad de Granada.
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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Almudena Carneiro-Barrera, PhD (656556547, acarneiro@uloyola.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnoea-hypopnoea index (AHI) (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?
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 17 Apr 2024.