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NCT06451601Completed

Intermittent Hypoxia-hyperoxia Therapy in Obese Patients (IHHTOP)

The Metabolic and Respiratory Effects of Intermittent Hypoxia-hyperoxia Therapy in Obese Patients Within the Complex Management of Medical Rehabilitation

Source: ClinicalTrials.gov · Last updated 11 Jun 2024

Brief summary (registry, in English)

Obesity represents the excessive or abnormal accumulation of adipose tissue in the body, which affects health through its association with the risk of developing diabetes mellitus, cardiovascular and pulmonary diseases and hypertension. Obesity can cause significant respiratory changes, so obese patients present pulmonary complications more frequently than individuals with normal weight. Intermittent hypoxia (IH) represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes. Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions. This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients, focusing on metabolic and respiratory effects. The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity. A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group. The intervention group will receive IHHT while the control group will not receive this therapy. All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures. The study's results will be used to determine whether IHHT benefits the patients who follow it. This study is designed to contribute to the existing body of knowledge on treating obese patients. The results of the study will be of interest to clinicians, researchers, and patients.

Status (registry)
Completed
Study type
Interventional
Enrollment
70 (actual)
First submitted
24 May 2024
Start date
1 Apr 2024
Primary completion date
6 May 2024
Lead sponsor
Balnear and Rehabilitation Sanatorium Techirghiol
Diseases
Obesity
NCT number
NCT06451601

What you commit to

  • Study type: Interventional
  • Participants enrolled: 70
  • From 1 Apr 2024 to the primary completion date, 6 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • patients presenting contraindications to intermittent hypoxia-hyperoxia therapy

Age

  • age under 40 or over 75 years

Other

  • BMI \<30 kg/m2
  • refusal to sign the informed consent form
  • patients presenting contraindications to complex medical rehabilitation treatment

Who the study is looking for

  • patients with BMI \>30 kg/m2
  • aged between 40-75 years
  • patients to sign the informed consent form
  • patients to be compensated and to have medical treatment for associated pathologies

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Balneal and Rehabilitation Sanatorium Techirghio
Coordinator of this site? Confirm its status
TechirghiolRomaniaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.