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NCT03857802: ENISH
Efficiency of a Nursing Intervention in Sleep Hygiene
NA trial testing Sleep hygiene intervention in Sleep Disorder in 86 participants. Completed in 10 January 2020.
15 December 2018
Quick facts
| Lead sponsor | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 86 |
| Start date | 1 September 2017 |
| Primary completion | 15 December 2018 |
| Estimated completion | 10 January 2020 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Sleep hygiene intervention
Conditions studied
- Sleep Disorder — all drugs for Sleep Disorder →
- Metabolic Glucose Disorders — all drugs for Metabolic Glucose Disorders →
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →
Who can join
18 and older, any sex, with Sleep Disorder or Metabolic Glucose Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: The relationship between the appearance of insulin resistance phenomena and insufficient or poor-quality sleep is scientifically documented. Objectives: To determine the effectiveness of an intervention based on behavioural techniques on sleep in the nursing consultation in the Primary Care setting to improve the level of HbA1c in patients diagnosed with diabetes mellitus 2 (DM2) or prediabetes. Hypothesis: Patients diagnosed with DM2 or prediabetes with poor sleep quality would improve their HbA1c levels after an intervention on healthier sleep hygiene practices. Sleeping 6 or less hours in adults diagnosed with DM2 or prediabetes would be related to worse metabolic control results. Patients diagnosed with DM2 or prediabetes who would value their sleep as poor quality would have poorer metabolic control. Methodology: Design: Not masked randomized clinical trial. Target population: Patients diagnosed up to the time of DM2 (E11) or prediabetes (R73, R73.9) with age over 18 attending the chronic nurses' follow-up visits of the Basic Health Area of Balaguer in the time range from November 2017 to December 2018. Determinations: Dependent variables: Glycemia and HbA1c. Independent variables: Sex, age, value of the Pittsburgh Sleep Quality Index (PSQI), declared hours of sleep, sleep efficiency, body mass index (BMI), pharmacologic antidiabetic treatment, changes in it, changes in diet, physical exercise and sleep hygiene. Statistical analysis: Analysis of the comparability of the groups and calculation of the confidence interval of the difference in the glycaemic values and HbA1c at the end of the follow-up, with respect to the initiation within the intervention group and within the control, and control group with respect to the group intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03857802
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03857802 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Last refreshed: 7 August 2020
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