A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C,
does it really help with Improved objective sleep-onset latency and sleep efficiency in adults with insomnia?
research showsGrade D. In a two-night sham-controlled trial of 106 adults with insomnia, both prespecified co-primary PSG endpoints were null. The between-group difference was -7.9 minutes for absolute latency to persistent sleep, 95% CI -18.4 to 2.6, P=.092, and +0.5 percentage points for sleep efficiency, -3.4 to 4.5, P=.759. Positive supportive latency measures do not replace those failures.
ads claimMarketing can foreground favorable secondary latency measures and imply drug-like sleep onset while omitting that both prespecified PSG efficacy endpoints were null.
Useful facts when choosing a product
- The tested system maintained forehead therapy at 14-16°C.
- It is not equivalent to an ordinary cold pack.
- Efficacy follow-up covered two nights.
Chamgap Semantic Classification Code
Permanent code issued
P.forehead-cooling-device.device.insomnia-objective-sleep-endpoints.improve.shamProcedures, devices and tests > A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C > Device delivered > Improved objective sleep-onset latency and sleep efficiency in adults with insomnia > Improvement claim > Sham
Codex retrospectively verified the principal intervention, delivery, population, endpoint, and comparator from the existing reviewed verdict and issued a permanent semantic code. Secondary outcomes on the page are not transferred as separate claims. The code identifies the intervention and claim; it never contains the evidence grade, score, or safety result.
Exact Claim Classification
These independent facets prevent evidence from different forms, routes, populations, effects, and comparators from being mixed.
| Intervention class | P · Procedure, surgery, device, or test |
|---|---|
| Canonical ingredient or intervention | A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C |
| Source or part used | Plant source not applicable; specified device or procedure |
| Formulation or processing | A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C |
| Route | Device delivered |
| Dose | A forehead temperature-regulating device delivering frontal thermal therapy at 14-16°C |
| Duration | Two nights |
| Population | 106 adults with insomnia, two nights |
| Effect or condition | Improved objective sleep-onset latency and sleep efficiency in adults with insomnia |
| Primary endpoint | Co-primary PSG endpoints of absolute latency to persistent sleep and absolute sleep efficiency |
| Comparator | Sham |
| Duplicate-detection key | forehead-cooling-device|device|106 adults with insomnia, two nights|insomnia-objective-sleep-endpoints|Two nights |
What the research actually shows
A total of 106 adults with diagnosed insomnia were randomized to active or sham therapy for two nights. The co-primary absolute latency and sleep-efficiency results had P=.092 and P=.759. Relative latency and some sleep-stage latency measures were positive supportive analyses.
Why this is classified as D (28)
Two null prespecified co-primary PSG endpoints plus n=106, two-night exposure, and developer involvement give D with 28 points.
Counterpoint. Acute tolerability was broadly similar to sham, but longer-term efficacy and safety need separate trials.
Rejudgment record. Codex full-text cross-check — Applied the null results of both prespecified co-primary PSG endpoints, n=106, two-night follow-up, developer involvement, and primary-failed/secondary-positive pattern
| Endpoint | S | Surrogate marker - laboratory or imaging measures |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E0 | Null |
| Precision | C0 | The confidence interval leaves room for benefit |
Stored derived and displayed grades match; this is not a current recalculation or validity check (D).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Improved absolute latency to persistent sleep | D | Null at P=.092. |
| Improved absolute sleep efficiency | D | Null at P=.759. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| Roth T et al. 2018 | Prospective randomized sham-controlled trial | 106 adults with insomnia, two nights | NIH/NHLBI support plus Ebb Therapeutics device and study involvement; company founder/executive as author | Co-primary PSG endpoints of absolute latency to persistent sleep and absolute sleep efficiency | -7.9 minutes (95% CI -18.4 to 2.6), P=.092; +0.5 percentage points (-3.4 to 4.5), P=.759 | Failed prespecified co-primary efficacy test |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-09-07).
Final verification and publication gate: Codex · Evidence date: 2026-09-07 · Corrections: none
Cite this verdict
[Chamgap] No Benefit of a Forehead-Cooling Device for Objective Sleep Latency and Efficiency in Insomnia — Evidence Grade D·28. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/sleep/forehead-cooling-device-insomnia-coprimary-null/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.